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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
10-Q
(Mark One)
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☒
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
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For the quarterly period ended
June 30, 2022
OR
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☐
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
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For the transition period from ___________________ to
___________________
Commission File Number:
001-40384
TALARIS THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
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Delaware
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83-2377352
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( State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification No.)
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93 Worcester St.
Wellesley,
MA
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02481
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(Address of principal executive offices)
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(Zip Code)
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Registrant’s telephone number, including area code:
(502)
398-9250
Securities registered pursuant to Section 12(b) of the
Act:
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Title of each class
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Trading
Symbol(s)
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Name of each exchange on which registered
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Common Stock, par value $0.0001 per share
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TALS
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The Nasdaq Global Market
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Indicate by check mark whether the registrant (1) has filed all
reports required to be filed by Section 13 or 15(d) of the
Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file
such reports), and (2) has been subject to such filing requirements
for the past 90 days.
Yes
☒ No ☐
Indicate by check mark whether the registrant has submitted
electronically every Interactive Data File required to be submitted
pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter)
during the preceding 12 months (or for such shorter period that the
registrant was required to submit such files).
Yes
☒ No ☐
Indicate by check mark whether the registrant is a large
accelerated filer, an accelerated filer, a non-accelerated filer,
smaller reporting company, or an emerging growth company. See the
definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule
12b-2 of the Exchange Act.
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Large accelerated filer
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☐
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Accelerated filer
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☐
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Non-accelerated filer
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☒
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Smaller reporting company
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☒
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Emerging growth company
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☒
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If an emerging growth company, indicate by check mark if the
registrant has elected not to use the extended transition period
for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange
Act.
☐
Indicate by check mark whether the registrant is a shell company
(as defined in Rule 12b-2 of the Exchange Act). Yes
☐
No ☒
As of August 1, 2022, the registrant had
41,698,054
shares of common stock, $0.0001 par value per share,
outstanding.
Table of Contents
i
SUMMARY OF THE MATERIAL RISKS ASSOCIATED WITH OUR
BUSINESS
Our business is subject to numerous risks and uncertainties,
including those described in Part II, Item 1A. "Risk Factors" in
this Quarterly Report on Form 10-Q (this "Quarterly Report"). The
principal risks and uncertainties affecting our business include
the following:
•
Our business substantially depends upon the successful development
and regulatory approval of FCR001, our lead product candidate. If
we are unable to obtain regulatory approval for FCR001, our
business may be materially harmed.
•
We are a late-stage clinical biotechnology company and we have
incurred net losses since our inception. We anticipate that we will
continue to incur significant net losses for the foreseeable
future, and may never achieve or maintain
profitability.
•
We have not yet completed any registrational trials and have no
history of commercializing products, which may make it difficult to
evaluate the success of our business to date and to assess our
future viability.
•
Our product candidates represent a novel therapeutic approach that
could result in heightened regulatory scrutiny. The regulatory
landscape that applies to our Facilitated Allo-HSCT Therapy is
rigorous, complex, uncertain and subject to change.
•
Clinical drug development involves a lengthy and expensive process
with an uncertain outcome, and the inability to successfully and
timely conduct clinical trials and obtain regulatory approval for
our product candidates would substantially harm our
business.
•
If we experience delays or difficulties in the enrollment of
patients in clinical trials, development of our product candidate
may be delayed or prevented, which would have a material adverse
effect on our business.
•
The results of preclinical studies or earlier clinical trials are
not necessarily predictive of future results. Our existing product
candidates in clinical trials, and any other product candidate we
advance into clinical trials, may not have favorable efficacy or
safety in later clinical trials or receive regulatory
approval.
•
Interim, “top line” or preliminary data from our clinical trials
that we may announce or share with regulatory authorities from time
to time may change as more patient data become available and are
subject to audit and verification procedures that could result in
material changes in the final data.
•
Our product candidates, or associated conditioning regimens or
treatment protocols, may cause undesirable side effects, or have
other properties that could delay or prevent their regulatory
approval, limit the commercial profile of an approved label or
result in significant negative consequences following any
regulatory approval.
•
We intend to develop FCR001, and potentially future product
candidates, in other indications and in combination with other
therapies, which exposes us to additional risks. Combination
therapies and additional indications involve additional complexity
and risk that could delay or cause our programs to stall or fail;
development of such programs may be more costly, may take longer to
achieve regulatory approval and may be associated with
unanticipated adverse events.
•
Even if our product candidates receive regulatory approval, we will
still face extensive ongoing regulatory requirements and continued
regulatory review, which may result in significant additional
expense, and our products may still face future development and
regulatory difficulties.
•
We currently operate our own manufacturing facility and intend to
scale-up our manufacturing and processing approaches to
appropriately address our anticipated commercial needs for FCR001,
which will require significant resources. We may fail to
successfully operate our facility, which could adversely affect our
clinical trials and the commercial viability of our product
candidates.
•
Our product candidates are uniquely manufactured for each patient
and we may encounter difficulties in production, particularly with
respect to scaling our manufacturing capabilities.
•
If our manufacturing facility is damaged or destroyed or production
at our manufacturing facility is otherwise interrupted, our
business would be negatively affected.
•
We are dependent on a limited number of suppliers and, in some
cases sole suppliers, for some of our components and materials used
in our product candidates.
•
We rely on third parties to conduct our clinical trials and perform
some of our research and preclinical studies. If these third
parties do not satisfactorily carry out their contractual duties or
fail to meet expected deadlines, our development programs may be
delayed or subject to increased costs, each of which may have an
adverse effect on our business and prospects.
ii
•
We depend substantially on intellectual property licensed from the
University of Louisville Research Foundation Inc. (“ULRF”), and
termination of this license could result in the loss of significant
rights, which would materially harm our business.
•
We expect the product candidates we develop will be regulated as
biological products, or biologics, and therefore they may be
subject to competition sooner than anticipated.
•
If we are unable to obtain and maintain sufficient intellectual
property protection for our product candidates and manufacturing
process, or if the scope of the intellectual property protection is
not sufficiently broad, our ability to commercialize our product
candidates successfully and to compete effectively may be adversely
affected.
•
Our business has been adversely affected by the ongoing COVID-19
pandemic, and could be further adversely affected by the effects
this and other of public health epidemics in regions where we, or
third parties on which we rely have significant research,
development or production facilities, concentrations of clinical
trial sites or other business operations.
•
Geopolitical and military conflict such as the ongoing warfare in
Ukraine, could cause a disruption of the development of our product
candidates and adversely impact our business.
iii
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-1 contains forward-looking
statements within the meaning of Section 27A of the Securities Act
of 1933, as amended (the “Securities Act”), and Section 21E of the
Securities Exchange Act of 1934, as amended (the “Exchange Act”).
All statements other than statements of historical fact are
“forward-looking statements” for purposes of this Annual Report on
Form 10-K. In some cases, you can identify forward-looking
statements by terminology such as “anticipate,” “believe,” “could,”
“estimate,” “expects,” “intend,” “may,” “plan,” “potential,”
“predict,” “project,” “should,” “will,” “would” or the negative or
plural of those terms, and similar expressions.
Forward-looking statements include, but are not limited to,
statements about:
•
the success, cost and timing of our product development activities
and clinical trials, including statements regarding the timing of
initiation and completion of studies or trials and related
preparatory work, the period during which the results of the trials
will become available, and our research and development
programs;
•
the potential for COVID-19 or other pandemic, epidemic or outbreak
of an infectious disease, to disrupt our business plans, product
development activities, ongoing clinical trials, including the
timing and enrollment of patients, the health of our employees and
the strength of our supply chain;
•
our expectations regarding the safety or efficacy profile of our
product candidates
•
our ability to advance any product candidate into or successfully
complete any clinical trial;
•
our ability to obtain regulatory approval for any of our
candidates;
•
our ability to successfully manufacture our product candidates for
future clinical trials or for commercial use, if
approved;
•
the ability to license additional intellectual property relating to
any future product candidates and to comply with our existing
license agreement;
•
our ability to commercialize our products in light of the
intellectual property rights of others;
•
the success of competing therapies that are or become
available;
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our ability to obtain funding for our operations, including funding
necessary to complete further development and commercialization of
our product candidates;
•
the commercialization of our product candidates, if
approved;
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our plans to research, develop and commercialize our product
candidates;
•
our ability to attract collaborators with development, regulatory
and commercialization expertise;
•
future agreements with third parties in connection with the
development or commercialization of our product candidates and any
other approved product;
•
the size and growth potential of the markets for our product
candidates, and our ability to serve those markets;
•
the rate and degree of market acceptance of our product
candidates;
•
regulatory and political developments in the United States and
foreign countries, including but not limited to the Russia-Ukraine
conflict and associated sanctions;
•
our ability to contract with third-party suppliers and
manufacturers and their ability to perform adequately;
•
our ability to attract and retain key scientific or management
personnel;
•
the accuracy of our estimates regarding expenses, future revenue,
capital requirements and needs for additional
financing;
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the impact of laws and regulations; and
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our expectations regarding our ability to obtain and maintain
intellectual property protection for our product
candidates.
iv
These factors should not be construed as exhaustive and should be
read in conjunction with the other cautionary statements that are
included in this Quarterly Report on Form 10-Q. The forward-looking
statements contained in this Quarterly Report on Form 10-Q are made
as of the date of this Quarterly Report on Form 10-Q, and we
undertake no obligations to publicly update or review any
forward-looking statement, whether as a result of new information,
future developments or otherwise. Therefore, you should not rely on
these forward-looking statements as representing our views as of
any date subsequent to the date of this Quarterly Report on Form
10-Q.
v
PART I—FINANCIAL
INFORMATION
Item 1. Financial
Statements.
TALARIS THERAPEUTICS, INC.
BALANCE
SHEETS
(in thousands, except share and per share amounts)
(unaudited)
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|
|
|
|
|
|
|
|
June 30, 2022
|
|
|
December 31, 2021
|
|
Assets
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
25,518
|
|
|
$
|
18,614
|
|
Marketable securities
|
|
|
181,594
|
|
|
|
225,357
|
|
Prepaid and other current assets
|
|
|
4,925
|
|
|
|
2,543
|
|
Total current assets
|
|
|
212,037
|
|
|
|
246,514
|
|
Property and equipment, net
|
|
|
5,730
|
|
|
|
4,804
|
|
Right-of-use assets
|
|
|
3,038
|
|
|
|
—
|
|
Other assets
|
|
|
111
|
|
|
|
104
|
|
Total assets
|
|
$
|
220,916
|
|
|
$
|
251,422
|
|
Liabilities and Stockholders’ Equity
|
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
2,075
|
|
|
$
|
2,556
|
|
Accrued expenses
|
|
|
4,421
|
|
|
|
5,431
|
|
Lease liability, current
|
|
|
835
|
|
|
|
—
|
|
Total current liabilities
|
|
|
7,331
|
|
|
|
7,987
|
|
Share repurchase liability
|
|
|
392
|
|
|
|
593
|
|
Other liabilities
|
|
|
21
|
|
|
|
33
|
|
Lease liability, net of current
|
|
|
2,430
|
|
|
|
—
|
|
Total liabilities
|
|
|
10,174
|
|
|
|
8,613
|
|
Commitments and
contingencies (Note 8)
|
|
|
|
|
|
|
Stockholders’ equity
|
|
|
|
|
|
|
Common stock, $0.0001 par
value,
140,000,000 shares
authorized and
39,995,881
issued and outstanding and
10,000,000 non-voting
shares authorized and
1,150,000
issued and outstanding as of June 30, 2022
and
140,000,000 shares
authorized
and
39,763,049 issued
and outstanding and
10,000,000 non-voting
shares authorized
and
1,150,000 issued
and outstanding as of December 31, 2021
|
|
|
4
|
|
|
|
4
|
|
Additional paid-in-capital
|
|
|
339,083
|
|
|
|
333,730
|
|
Accumulated deficit
|
|
|
(127,202
|
)
|
|
|
(90,847
|
)
|
Accumulated other comprehensive loss
|
|
|
(1,143
|
)
|
|
|
(78
|
)
|
Total stockholders’ equity
|
|
|
210,742
|
|
|
|
242,809
|
|
Total liabilities and stockholders’ equity
|
|
$
|
220,916
|
|
|
$
|
251,422
|
|
The accompanying notes are an integral part of these financial
statements.
1
TALARIS THERAPEUTICS, INC.
STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS
(in thousands, except share and per share amounts)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30,
|
|
|
Six months ended June 30,
|
|
|
|
2022
|
|
|
2021
|
|
|
2022
|
|
|
2021
|
|
Operating expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
$
|
13,187
|
|
|
$
|
7,570
|
|
|
$
|
27,383
|
|
|
$
|
14,473
|
|
General and administrative
|
|
|
5,228
|
|
|
|
3,487
|
|
|
|
9,446
|
|
|
|
5,589
|
|
Total operating expenses
|
|
|
18,415
|
|
|
|
11,057
|
|
|
|
36,829
|
|
|
|
20,062
|
|
Loss from operations
|
|
|
(18,415
|
)
|
|
|
(11,057
|
)
|
|
|
(36,829
|
)
|
|
|
(20,062
|
)
|
Interest and other income (expense), net
|
|
|
319
|
|
|
|
(295
|
)
|
|
|
474
|
|
|
|
(589
|
)
|
Net loss
|
|
$
|
(18,096
|
)
|
|
$
|
(11,352
|
)
|
|
$
|
(36,355
|
)
|
|
$
|
(20,651
|
)
|
Unrealized gain (loss) on marketable securities
|
|
|
(217
|
)
|
|
|
25
|
|
|
|
(1,065
|
)
|
|
|
47
|
|
Total comprehensive loss
|
|
$
|
(18,313
|
)
|
|
$
|
(11,327
|
)
|
|
$
|
(37,420
|
)
|
|
$
|
(20,604
|
)
|
Net loss
|
|
$
|
(18,096
|
)
|
|
$
|
(11,352
|
)
|
|
$
|
(36,355
|
)
|
|
$
|
(20,651
|
)
|
Net loss per common share, basic and diluted
|
|
|
(0.44
|
)
|
|
|
(0.41
|
)
|
|
|
(0.89
|
)
|
|
|
(1.19
|
)
|
Weighted average number of common shares outstanding used in
computation
of net loss per common share, basic and
diluted
|
|
|
41,088,085
|
|
|
|
27,373,165
|
|
|
|
41,034,447
|
|
|
|
17,322,734
|
|
The accompanying notes are an integral part of these financial
statements.
2
TALARIS THERAPEUTICS, INC.
STATEMENTS OF CONVERTIBLE PREFERRED
STOCK AND STOCKHOLDERS’ EQUITY
(in thousands, except share amounts)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series A
Convertible
Preferred Stock
|
|
|
Series A-1
Convertible Preferred
Stock
|
|
|
Series B
Convertible
Preferred Stock
|
|
|
|
Common Stock
|
|
|
Additional
|
|
|
|
|
|
Accumulated
Other
|
|
|
Total
|
|
|
|
Outstanding
Shares
|
|
|
Amount
|
|
|
Outstanding
Shares
|
|
|
Amount
|
|
|
Outstanding
Shares
|
|
|
Amount
|
|
|
|
Outstanding
Shares
|
|
|
Amount
|
|
|
Paid-in
Capital
|
|
|
Accumulated
Deficit
|
|
|
Comprehensive
Income (Loss)
|
|
|
Stockholders’
Equity (Deficit)
|
|
Balance at December 31, 2020
|
|
|
40,000,000
|
|
|
$
|
37,383
|
|
|
|
28,000,000
|
|
|
$
|
34,272
|
|
|
|
62,499,993
|
|
|
$
|
114,496
|
|
|
|
|
7,087,130
|
|
|
$
|
1
|
|
|
$
|
4,879
|
|
|
$
|
(43,014
|
)
|
|
$
|
(13
|
)
|
|
|
(38,147
|
)
|
Issuance of common stock upon
exercise of stock options
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
|
117,181
|
|
|
|
—
|
|
|
|
123
|
|
|
|
—
|
|
|
|
—
|
|
|
|
123
|
|
Stock-based compensation expense
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
|
—
|
|
|
|
—
|
|
|
|
835
|
|
|
|
—
|
|
|
|
—
|
|
|
|
835
|
|
Net loss
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(9,299
|
)
|
|
|
—
|
|
|
|
(9,299
|
)
|
Unrealized gain on marketable
securities
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
22
|
|
|
|
22
|
|
Balance at March 31, 2021
|
|
|
40,000,000
|
|
|
|
37,383
|
|
|
|
28,000,000
|
|
|
|
34,272
|
|
|
|
62,499,993
|
|
|
|
114,496
|
|
|
|
|
7,204,311
|
|
|
|
1
|
|
|
|
5,837
|
|
|
|
(52,313
|
)
|
|
|
9
|
|
|
|
(46,466
|
)
|
Issuance of common stock, net of
underwriting discounts and
issuance costs of $12,858,764
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
|
8,825,000
|
|
|
|
1
|
|
|
|
137,165
|
|
|
|
—
|
|
|
|
—
|
|
|
|
137,166
|
|
Conversion of convertible preferred
stock to common stock
|
|
|
(40,000,000
|
)
|
|
|
(37,383
|
)
|
|
|
(28,000,000
|
)
|
|
|
(34,272
|
)
|
|
|
(62,499,993
|
)
|
|
|
(114,496
|
)
|
|
|
|
24,392,498
|
|
|
|
2
|
|
|
|
186,149
|
|
|
|
—
|
|
|
|
—
|
|
|
|
186,151
|
|
Issuance of contingent common
stock
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
|
48,889
|
|
|
|
—
|
|
|
|
831
|
|
|
|
—
|
|
|
|
—
|
|
|
|
831
|
|
Issuance of common stock upon
exercise of stock options
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
|
100,436
|
|
|
|
—
|
|
|
|
102
|
|
|
|
—
|
|
|
|
—
|
|
|
|
102
|
|
Stock-based compensation expense
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
|
—
|
|
|
|
—
|
|
|
|
896
|
|
|
|
—
|
|
|
|
—
|
|
|
|
896
|
|
Net loss
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(11,352
|
)
|
|
|
—
|
|
|
|
(11,352
|
)
|
Unrealized gain on marketable
securities
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
25
|
|
|
|
25
|
|
Balance at June 30, 2021
|
|
|
—
|
|
|
$
|
—
|
|
|
|
—
|
|
|
$
|
—
|
|
|
|
—
|
|
|
$
|
—
|
|
|
|
|
40,571,134
|
|
|
$
|
4
|
|
|
$
|
330,980
|
|
|
$
|
(63,665
|
)
|
|
$
|
34
|
|
|
$
|
267,353
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2021
|
|
|
—
|
|
|
$
|
—
|
|
|
|
—
|
|
|
$
|
—
|
|
|
|
—
|
|
|
$
|
—
|
|
|
|
|
40,913,049
|
|
|
$
|
4
|
|
|
$
|
333,730
|
|
|
$
|
(90,847
|
)
|
|
$
|
(78
|
)
|
|
$
|
242,809
|
|
Issuance of common stock upon
exercise of stock options
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
|
110,819
|
|
|
|
—
|
|
|
|
131
|
|
|
|
—
|
|
|
|
—
|
|
|
|
131
|
|
Stock-based compensation expense
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
|
—
|
|
|
|
—
|
|
|
|
2,197
|
|
|
|
—
|
|
|
|
—
|
|
|
|
2,197
|
|
Net loss
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(18,259
|
)
|
|
|
—
|
|
|
|
(18,259
|
)
|
Unrealized loss on marketable
securities
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(848
|
)
|
|
|
(848
|
)
|
Balance at March 31, 2022
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
|
41,023,868
|
|
|
|
4
|
|
|
|
336,058
|
|
|
|
(109,106
|
)
|
|
|
(926
|
)
|
|
|
226,030
|
|
Issuance of common stock upon
exercise of stock options
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
|
101,851
|
|
|
|
0
|
|
|
|
102
|
|
|
|
—
|
|
|
|
—
|
|
|
|
102
|
|
Issuance of common stock under
2021 employee stock purchase
plan
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
|
20,162
|
|
|
|
0
|
|
|
|
77
|
|
|
|
—
|
|
|
|
—
|
|
|
|
77
|
|
Stock-based compensation expense
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
|
—
|
|
|
|
—
|
|
|
|
2,846
|
|
|
|
—
|
|
|
|
—
|
|
|
|
2,846
|
|
Net loss
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(18,096
|
)
|
|
|
—
|
|
|
|
(18,096
|
)
|
Unrealized loss on marketable
securities
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(217
|
)
|
|
|
(217
|
)
|
Balance at June 30, 2022
|
|
|
—
|
|
|
$
|
—
|
|
|
|
—
|
|
|
$
|
—
|
|
|
|
—
|
|
|
$
|
—
|
|
|
|
|
41,145,881
|
|
|
$
|
4
|
|
|
$
|
339,083
|
|
|
$
|
(127,202
|
)
|
|
$
|
(1,143
|
)
|
|
$
|
210,742
|
|
The accompanying notes are an integral part of these financial
statements.
3
TALARIS THERAPEUTICS, INC.
STATEMENTS OF
CASH FLOWS
(in thousands)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
Six months ended June 30,
|
|
|
|
2022
|
|
|
2021
|
|
Cash flows from operating activities:
|
|
|
|
|
|
|
Net loss
|
|
$
|
(36,355
|
)
|
|
$
|
(20,651
|
)
|
Adjustments to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
Depreciation and amortization
|
|
|
655
|
|
|
|
268
|
|
Accretion and amortization of marketable securities, net
|
|
|
(92
|
)
|
|
|
302
|
|
Amortization of right-of-use assets
|
|
|
384
|
|
|
|
—
|
|
Stock-based compensation expense
|
|
|
5,043
|
|
|
|
1,731
|
|
Fair value adjustment of contingent stock liability
|
|
|
—
|
|
|
|
735
|
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
Prepaid and other current assets
|
|
|
(2,382
|
)
|
|
|
(2,986
|
)
|
Other assets
|
|
|
(7
|
)
|
|
|
(75
|
)
|
Accounts payable
|
|
|
(84
|
)
|
|
|
497
|
|
Accrued expenses
|
|
|
(553
|
)
|
|
|
150
|
|
Operating lease liability
|
|
|
(262
|
)
|
|
|
—
|
|
Other liabilities
|
|
|
93
|
|
|
|
—
|
|
Net cash used in operating activities
|
|
|
(33,560
|
)
|
|
|
(20,029
|
)
|
Cash flows from investing activities:
|
|
|
|
|
|
|
Purchases of property and equipment
|
|
|
(2,433
|
)
|
|
|
(522
|
)
|
Purchases of marketable securities
|
|
|
(87,983
|
)
|
|
|
(174,844
|
)
|
Maturities of marketable securities
|
|
|
130,771
|
|
|
|
76,564
|
|
Net cash provided by (used in) investing activities
|
|
|
40,355
|
|
|
|
(98,802
|
)
|
Cash flows from financing activities:
|
|
|
|
|
|
|
Proceeds from issuance of common stock
|
|
|
—
|
|
|
|
139,523
|
|
Common stock issuance costs
|
|
|
—
|
|
|
|
(1,735
|
)
|
Payment of partial settlement of contingent stock
liability
|
|
|
—
|
|
|
|
(277
|
)
|
Proceeds from exercise of stock options
|
|
|
32
|
|
|
|
28
|
|
Proceeds from issuance of common stock under 2021 employee stock
purchase plan
|
|
|
77
|
|
|
|
—
|
|
Net cash provided by financing activities
|
|
|
109
|
|
|
|
137,539
|
|
Net increase in cash and cash equivalents
|
|
|
6,904
|
|
|
|
18,708
|
|
Cash and cash equivalents at beginning of period
|
|
|
18,614
|
|
|
|
17,589
|
|
Cash and cash equivalents at end of period
|
|
$
|
25,518
|
|
|
$
|
36,297
|
|
Supplemental disclosure of non-cash investing and financing
activities:
|
|
|
|
|
|
|
Property and equipment additions included in accounts payable
and
accrued expenses
|
|
$
|
174
|
|
|
$
|
72
|
|
Deferred issuance costs included in accounts payable and
accrued expenses
|
|
$
|
—
|
|
|
$
|
634
|
|
Issuance of shares of common stock in partial settlement of
contingent stock liability
accrued expenses
|
|
$
|
—
|
|
|
$
|
831
|
|
The accompanying notes are an integral part of these financial
statements.
4
TALARIS THERAPEUTICS, INC
NOTES TO FINANCIAL STATEMENTS
(unaudited)
1. Nature of Business and Liquidity
Talaris Therapeutics, Inc. (“Talaris” or the “Company”) is a
late-clinical stage, cell therapy company developing an innovative
method of allogeneic hematopoietic stem cell transplantation
(“allo-HSCT”), called Facilitated Allo-HSCT Therapy, that the
Company believes has the potential to transform the standard of
care in solid organ transplantation, certain severe autoimmune
diseases and certain severe blood, immune and metabolic disorders.
The Company believes that these target indications, individually
and collectively, represent a significant unmet need and commercial
opportunity. The Company maintains corporate offices in Boston,
Massachusetts, a laboratory in Houston, Texas and its cell
processing facility in Louisville, Kentucky.
Initial Public Offering
The Company completed an initial public offering (“IPO”) on May 11,
2021 in which the Company issued and sold
8,825,000
shares of its common stock at a public offering price of
$17.00
per share. The Company’s aggregate gross proceeds from the sale of
shares in the IPO was $150.0
million before underwriting discounts and commissions and other
expenses of approximately $12.9
million. Upon completion of the offering, the Company’s outstanding
convertible preferred stock was automatically converted into shares
of common stock and non-voting common stock. Following the IPO,
there were
no
shares of preferred stock outstanding. Prior to the IPO, on April
30, 2021, the Company’s board of directors and shareholders
approved a
one-for-5.35
reverse share split of issued and outstanding common shares and
incentive shares and a proportional adjustment to the existing
conversion ratios for the Company’s convertible preferred
stock.
Liquidity
The accompanying financial statements have been prepared assuming
that the Company will continue as a going concern. Management has
evaluated whether there are conditions and events that raise
substantial doubt about the Company’s ability to continue as a
going concern within one year after the date the financial
statements are issued. Since its inception, the Company has
incurred net losses and negative cash flows from operations. During
the six months ended June 30, 2022 and the year ended December 31,
2021,
the Company incurred a net loss of $36.4
million and $47.8
million, respectively, and used $33.6
million and $40.0
million in cash for operations, respectively. In addition, as
of
June 30, 2022,
the Company had an accumulated deficit of $127.2
million. The Company expects to continue to generate operating
losses and negative cash flows for the foreseeable future. The
Company currently expects the cash and cash equivalents of
$25.5
million and marketable securities of $181.6
million as of
June 30, 2022, will be sufficient to fund its operating expenses
and capital requirements for more than 12 months from the date the
financial statements are available to be issued.
Additional funding will be needed to finance future clinical,
pre-clinical, manufacturing and commercial activities. There is no
assurance the Company will be successful in obtaining such
additional financing on terms acceptable to it, if at all, and it
may not be able to enter into other arrangements. If the Company is
unable to obtain funding, it could be forced to delay, reduce or
eliminate our research and development programs, portfolio
expansion or commercialization efforts, which could adversely
affect its business prospects and ability to continue
operations.
The Company is subject to risks common to companies in the
biopharmaceutical industry. There can be no assurance that the
Company’s research and development will be successfully completed,
that adequate protection for its intellectual property will be
maintained, that any products developed will obtain required
regulatory approval, or that any approved products will be
commercially viable. Even if the development efforts are
successful, it is uncertain when, if ever, the Company will
generate significant product sales and ultimately net
income.
Coronavirus Pandemic
In March 2020, the World Health Organization declared the COVID-19
outbreak a pandemic. The worldwide COVID-19 pandemic has affected
and may affect in the future the Company’s ability to initiate and
complete preclinical studies, delay the initiation and completion
of its current and planned clinical trials, disrupt regulatory
activities or have other adverse effects on its business, results
of operations, financial condition and prospects. In addition, the
pandemic has caused substantial disruption in the financial markets
and may adversely impact economies worldwide, both of which could
adversely affect the Company’s business, operations and ability to
raise funds to support its operations.
5
The Company cannot be certain what the overall impact of the
COVID-19 pandemic will be on its business, and it has the potential
to adversely affect its business, financial condition, results of
operations and prospects.
2. Summary of Significant Accounting Policies
Basis of Presentation
The financial statements have been prepared in accordance with
generally accepted accounting principles in the United States of
America (“U.S. GAAP”).
Use of Estimates
The preparation of financial statements in conformity with U.S.
GAAP requires management to make judgments, assumptions, and
estimates that affect the reported amounts of assets and
liabilities, the disclosure of contingent assets and liabilities at
the date of financial statements, and the reported amounts of
income and expense during the reporting period. The most
significant estimates relate to the determination of the fair value
of stock option grants and estimates related to the amount of
prepaid and accrued research and development expenses as of the
balance sheet date. For periods presented prior to the Company’s
IPO, significant estimates were used in the determination of the
fair value of the Company’s common stock. Management evaluates its
estimates and assumptions on an ongoing basis using historical
experience and other factors, including the current economic
environment, and makes adjustments when the facts and circumstances
dictate. These estimates are based on information available as of
the date of the financial statements; therefore, actual results
could differ from those estimates.
Cash and Cash Equivalents
The Company considers all highly liquid investments with an
original maturity of three months or less at the date of purchase
to be cash equivalents. As of June 30, 2022 and December 31,
2021,
cash and cash equivalents consisted primarily of checking and
savings deposits, money market fund holdings, and commercial
paper.
Marketable Securities
The Company classifies its marketable securities as
available-for-sale securities, which are carried at their fair
value based on the quoted market prices of the securities.
Unrealized gains and losses are reported as accumulated other
comprehensive loss, a separate component of stockholders’ deficit.
Realized gains and losses on available-for-sale securities are
included in net loss in the period earned or incurred.
Property and Equipment
Property and equipment are stated at cost less accumulated
depreciation. Depreciation expense is recognized using the
straight-line method over the estimated useful life of each asset.
Equipment and furniture and fixtures are depreciated over
five
or
seven year
lives. Leasehold improvements are
amortized over the shorter of the lease term or the
five-year
estimated useful life of the asset.
Computer equipment and computer software are depreciated
over
three years.
Upon retirement or sale, the cost of assets disposed of and the
related accumulated depreciation are removed from the accounts and
any resulting gain or loss is included in loss from operations.
Expenditures for repairs and maintenance are expensed as
incurred.
Impairment of Long-Lived Assets
The Company evaluates its long-lived assets, which consist
primarily of property and equipment, for impairment whenever events
or changes in circumstances indicate that the carrying amount of
such assets may not be recoverable. Recoverability of assets to be
held and used is measured by a comparison of the carrying amount of
an asset to the future undiscounted net cash flows expected to be
generated by the asset. If such assets are considered to be
impaired, the impairment to be recognized is measured by the amount
by which the carrying amount of the asset exceeds the fair value of
the asset.
No
impairments have been identified as of
June 30, 2022 and December 31, 2021.
Concentration of Credit Risk
Financial instruments that potentially subject the Company to
significant concentration of credit risk consist primarily of cash
and cash equivalents. The Company’s investment policy includes
guidelines regarding the quality of the financial institutions and
financial instruments and defines allowable investments that it
believes minimizes the exposure to concentration of credit risk.
The Company may invest in money market funds (minimum of
$1
billion
in assets), U.S. Treasury securities, corporate debt, bank debt,
U.S.
6
government-related
agency securities, other sovereign debt, municipal debt and
commercial paper. These deposits may exceed federally insured
limits. The Company has not experienced any losses historically in
these accounts and believes that it is not exposed to significant
credit risk as its deposits are held at financial institutions that
management believes to be of high credit quality.
Fair Value of Financial Instruments
Fair value is defined as the price that the Company would receive
to sell an investment in a timely transaction or pay to transfer a
liability in a timely transaction with an independent buyer in the
principal market, or in the absence of a principal market, the most
advantageous market for the investment or liability. A framework is
used for measuring fair value utilizing a three-tier hierarchy that
prioritizes the inputs to valuation techniques used to measure fair
value. The hierarchy gives the highest priority to unadjusted
quoted prices in active markets for identical assets or liabilities
(Level 1 investments) and the lowest priority to unobservable
inputs (Level 3 investments).
The three levels of the fair value hierarchy are as
follows:
•
Level 1 inputs:
Unadjusted quoted prices in active markets that are accessible at
the measurement date for identical, unrestricted assets or
liabilities;
•
Level 2 inputs:
Quoted prices in markets that are not considered to be active or
financial instrument valuations for which all significant inputs
are observable, either directly or indirectly; and
•
Level 3 inputs:
Prices or valuations that require inputs that are both significant
to the fair value measurement and unobservable.
Financial instruments are categorized in their entirety based on
the lowest level of input that is significant to the fair value
measurement. The assessment of the significance of a particular
input to the fair value measurement requires judgment and considers
factors specific to the investment.
The Company’s money market funds and marketable securities are
carried at fair value determined according to the fair value
hierarchy described above (Level 1 and Level 2,
respectively).
The Company’s contingent stock liability as of
June 30, 2021
(see Note 3) is carried at fair value determined according to the
fair value hierarchy described above (Level 3).
Research and Development Expenses
Research and development expenses include (i) employee-related
expenses, including salaries, benefits, travel and stock-based
compensation expense; (ii) external research and development
expenses incurred under arrangements with third parties, such as
contract research organization agreements, investigational sites,
and consultants; (iii) the cost of acquiring, developing, and
manufacturing clinical study materials; (iv) costs associated with
preclinical and clinical activities and regulatory operations; (v)
costs incurred in development of intellectual property; and (vi) an
allocated portion of facilities and other infrastructure costs
associated with our research and development activities. Costs
incurred in connection with research and development activities are
expensed as incurred.
The Company enters into consulting, research, and other agreements
with commercial entities, researchers, universities, and others for
the provision of goods and services. Such arrangements are
generally cancelable upon reasonable notice and payment of costs
incurred. Costs are considered incurred based on an evaluation of
the progress to completion of specific tasks under each contract
using information and data provided by the respective vendors,
including the Company’s clinical sites. These costs consist of
direct and indirect costs associated with specific projects, as
well as fees paid to various entities that perform certain research
on behalf of the Company. Depending upon the timing of payments to
the service providers, the Company recognizes prepaid expenses or
accrued expenses related to these costs. These accrued or prepaid
expenses are based on management’s estimates of the work performed
under service agreements, milestones achieved, and experience with
similar contracts. The Company monitors each of these factors and
adjusts estimates accordingly.
Stock-Based Compensation
The Company measures all stock options and other stock-based awards
granted to employees, nonemployees, and directors based on the fair
value on the date of the grant and recognizes stock-based
compensation expense of those awards over the requisite service
period, which is generally the vesting period of the respective
award. Generally, the Company issues stock option awards with only
service-based vesting conditions and records the expense for these
awards using the straight-line method. The Company’s policy is to
account for forfeitures when they occur.
7
The Company classifies stock-based compensation expense in its
statement of operations in the same manner in which the award
recipient’s payroll costs are classified or in which the award
recipients’ service payments are classified.
The fair value of each stock option grant is estimated on the date
of grant using the Black-Scholes option-pricing model. The Company
recently completed its IPO and lacks company-specific historical
and implied volatility information. Therefore, it estimates its
expected stock volatility based on the historical volatility of a
publicly traded set of peer companies and expects to continue to do
so until it has adequate historical data regarding the volatility
of its own traded stock price. The expected term of the Company’s
stock options has been determined utilizing the “simplified” method
for awards that qualify as “plain-vanilla” options. The expected
term of stock options granted to non-employees is equal to the
contractual term of the option award. The risk-free interest rate
is determined by reference to the US Treasury yield curve in effect
at the time of grant of the award for time periods approximately
equal to the expected term of the award. Expected dividend yield
is
zero
because the Company has never paid cash dividends on common stock
and does not expect to pay any cash dividends in the foreseeable
future.
Prior to the Company’s IPO, the Company considered the estimated
fair value of the common stock as of the measurement date in
determining the exercise price for options granted. The estimated
fair value of the common stock was determined at each grant date
based upon a variety of factors, including the illiquid nature of
the common stock, arm’s-length sales of the Company’s capital stock
(including convertible preferred stock), the effect of the rights
and preferences of the preferred shareholders, and the prospects of
a liquidity event. Among other factors are the Company’s financial
position and historical financial performance, forecasted future
operations of the Company, an evaluation or benchmark of the
Company’s competition, and the current business climate in the
marketplace. Significant changes to the key assumptions underlying
the factors used could result in different fair values of common
stock at each valuation date. The fair value for options granted
since the Company’s IPO are based on the closing stock price on
grant date.
Income Taxes
The Company accounts for income taxes using the asset and liability
method, which requires the recognition of deferred tax assets and
liabilities for the expected future tax consequences of events that
have been recognized in the financial statements or in the
Company’s tax returns. Deferred tax assets and liabilities are
determined on the basis of the differences between the financial
statements and tax basis of assets and liabilities using enacted
tax rates in effect for the year in which the differences are
expected to reverse. Changes in deferred tax assets and liabilities
are recorded in the provision for income taxes. The Company
assesses the likelihood that its deferred tax assets will be
recovered from future taxable income and, to the extent it
believes, based upon the weight of available evidence, that it is
more likely than not that all or a portion of the deferred tax
assets will not be realized, a valuation allowance is established
through a charge to income tax expense. Potential for recovery of
deferred tax assets is evaluated by estimating the future taxable
profits expected and considering prudent and feasible tax planning
strategies.
The Company accounts for uncertainty in income taxes recognized in
the financial statements by applying a two-step process to
determine the amount of tax benefit to be recognized. First, the
tax position must be evaluated to determine the likelihood that it
will be sustained upon external examination by the taxing
authorities. If the tax position is deemed more likely than not to
be sustained, the tax position is then assessed to determine the
amount of benefit to recognize in the financial statements. The
amount of the benefit that may be recognized is the largest amount
that has a greater than 50% likelihood of being realized upon
ultimate settlement. The provision for income taxes includes the
effects of any resulting tax reserves, or unrecognized tax
benefits, that are considered appropriate as well as the related
net interest and penalties.
The Company provides reserves for potential payments of tax to
various tax authorities related to uncertain tax positions. These
reserves are based on a determination of whether and how much of a
tax benefit taken by the Company in its tax filings or positions is
more likely than not to be realized following resolution of any
potential contingencies present related to the tax benefit.
Potential interest and penalties associated with such uncertain tax
positions are recorded as a component of income tax expense. The
Company had no significant uncertain tax positions as of June 30,
2022 and December 31, 2021.
Basic and Diluted Net Loss Per Share
The
Company calculates basic and diluted net loss per share using the
two-class method. The two-class method requires income available to
common stockholders for the period to be allocated between common
stock and participating securities based upon their respective
rights to receive dividends as if all income for the period had
been distributed. The Company’s Series A convertible preferred
stock, Series A-1 convertible preferred stock and Series B
convertible preferred stock were participating securities. These
participating securities did not contractually require the holders
of such shares to participate in the Company’s losses. As such, net
losses for the years presented were not allocated to the Company’s
participating securities. Accordingly, basic net loss per share is
computed by dividing the net loss by the weighted average number of
common shares outstanding during the period, without consideration
of potential dilutive securities. Diluted net loss per share is
computed by dividing the net loss by the sum of the weighted
average number of common shares outstanding during the period plus
the dilutive effects of potentially dilutive securities outstanding
during the period. Potentially dilutive
8
securities
include vested and unexercised stock options, restricted stock
issued upon early exercise of stock options, convertible preferred
shares and contingent stock liabilities. The dilutive effect of
stock options and contingent stock liabilities are computed using
the treasury stock method and the dilutive effect of convertible
preferred shares is calculated using the if-converted method. The
Company has generated a net loss for all periods presented,
therefore diluted net loss per share is the same as basic net loss
per share since the inclusion of potentially dilutive securities
would be anti-dilutive.
Segments
Operating segments are defined as components of an entity for which
separate financial information is made available and is regularly
evaluated by the chief operating decision maker (“CODM”) in making
decisions regarding resource allocation and assessing performance.
The Company’s CODM is the chief executive officer and operations
are managed as a single segment for the purposes of assessing
performance and making operating decisions.
Comprehensive Loss
Comprehensive loss represents net loss for the period plus the
results of certain other changes in stockholders’ equity. The
Company’s comprehensive loss included unrealized gains and losses
related to marketable securities for the six months ended June 30,
2022 and 2021.
Recently Issued Accounting Pronouncements
In February 2016, the FASB issued ASU No. 2016-02,
Leases (Topic 842),
and subsequently has issued additional guidance (collectively, “ASC
842”), which requires companies to generally recognize operating
and financing lease liabilities and corresponding right-of-use
assets on the balance sheet. The Company adopted ASC 842 on January
1, 2022 using the modified retrospective approach, with no
restatement of prior periods. Upon adoption, the Company elected
the package of transitional practical expedients which allowed the
Company to carry forward prior conclusions related to whether any
expired or existing contracts are or contain leases, the lease
classification for any expired or existing leases and initial
direct costs for existing leases. In addition, the Company made an
accounting policy election to not apply the recognition
requirements in the leasing standards to short-term leases, which
is a lease that at commencement date has a lease term of 12 months
or less and does not contain a purchase option that it is
reasonably certain to exercise.