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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
10-Q
(Mark One)
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the quarterly period ended
September 30,
2022
OR
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the transition period from
to
Commission File Number:
001-38443
Cogent Biosciences, Inc.
(Exact name of registrant as specified in its charter)
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Delaware
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46-5308248
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification Number)
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275 Wyman Street,
3rd Floor
Waltham,
Massachusetts
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02451
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(Address of principal executive offices)
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(Zip code)
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(617)
945-5576
(Registrant’s telephone number, including area code)
200 Cambridge Park Drive,
Suite 2500
Cambridge,
Massachusetts
02140
(Former name or former address, if changed since last
report)
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, $0.001 Par Value
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COGT
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The Nasdaq Global Select 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, a
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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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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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
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No
☒
As of November 11, 2022, there were
69,893,434
shares of the registrant’s Common Stock, $0.001 par value per
share, outstanding.
Summary of the Material Risks Associated with Our
Business
Our business is subject to numerous risks and uncertainties that
you should be aware of in evaluating our business. These risks
include, but are not limited to, the following:
•
Our business is highly dependent on the success of our
bezuclastinib program and our ability to discover and develop
additional product candidates. We may not be successful in our
efforts to develop bezuclastinib or expand our pipeline of drug
candidates.
•
Since the number of patients that we have dosed to date in our
clinical trials is small, the results from such clinical trials may
be less reliable than results achieved in larger clinical
trials.
•
Clinical trials are expensive, time-consuming, and difficult to
design and implement.
•
The current pandemic of the novel coronavirus, or COVID-19, and the
future outbreak of other highly infectious or contagious diseases,
could seriously harm our development efforts, increase our costs
and expenses and have a material adverse effect on our business,
financial condition and results of operations.
•
We face significant competition from other biotechnology and
pharmaceutical companies, and our operating results will suffer if
we fail to compete effectively.
•
We may choose not to develop a potential product candidate, or we
may suspend, deprioritize or terminate one or more discovery
programs or preclinical or clinical product candidates or
programs.
•
Regulatory authorities, including the U.S. Food and Drug
Administration (“FDA”), may disagree with our regulatory plan and
we may fail to obtain regulatory approval of our product
candidates.
•
The impact on our business of healthcare legislation and other
changes in the healthcare industry and in healthcare spending is
currently unknown and may adversely affect our business
model.
•
We contract with third parties for the manufacture of our product
candidates for preclinical development and clinical trials. This
reliance on third parties increases the risk that we will not have
sufficient quantities of our drug candidates or such quantities at
an acceptable cost, which could delay, prevent or impair our
development or commercialization efforts.
•
The third parties upon whom we rely for the supply of the API and
drug product used in bezuclastinib are our sole source of supply,
and the loss of any of these suppliers could significantly harm our
business.
•
We may form or seek collaborations or strategic alliances or enter
into additional licensing arrangements in the future, and we may
not realize the benefits of such collaborations, alliances or
licensing arrangements.
•
If our efforts to protect the proprietary nature of the
intellectual property related to our technologies are not adequate,
we may not be able to compete effectively in our
market.
•
We are highly dependent on our key personnel, and if we are not
successful in attracting and retaining highly qualified personnel,
we may not be able to successfully implement our business
strategy.
•
We have incurred net losses in every year since our inception and
anticipate that we will continue to incur net losses in the
future.
•
We will require substantial additional funding. If we fail to
obtain additional financing when needed, or on attractive terms, we
may be unable to complete the development and commercialization of
our product candidates
•
The price of our stock may be volatile, and you could lose all or
part of your investment.
The summary risk factors described above should be read together
with the text of the full risk factors in
Item 1A. “Risk Factors”
and the other information set forth in this Quarterly Report on
Form 10-Q, including our consolidated financial statements and the
related notes, as well as in other documents that we file with the
SEC. The risks summarized above or described in full below are not
the only risks that we face. Additional risks and uncertainties not
precisely known to us, or that we currently deem to be immaterial
may also materially adversely affect our business, financial
condition, results of operations and future growth
prospects.
This Quarterly Report on Form 10-Q contains forward-looking
statements, which reflect our current views with respect to, among
other things, our operations and financial performance. All
statements other than statements of historical facts contained in
this Quarterly Report on Form 10-Q, including statements regarding
our strategy, future operations, future financial position, future
revenue, projected costs, prospects, plans, objectives of
management and expected market growth are forward-looking
statements. These statements involve known and unknown risks,
uncertainties, and other important factors that may cause our
actual results, performance or achievements to be materially
different from any future results, performance, or achievements
expressed or implied by the forward-looking statements.
i
In some cases, you can identify forward-looking statements by terms
such as “may,” “should,” “expects,” “might,” “plans,”
“anticipates,” “could,” “intends,” “target,” “projects,”
“contemplates,” “believes,” “estimates,” “predicts,” “potential,”
“seek,” “would” or “continue,” or the negative of these terms or
other similar expressions. The forward looking statements in this
Quarterly Report on Form 10-Q 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. Although we believe that the
expectations reflected in the forward-looking statements are
reasonable, we cannot guarantee that the future results, levels of
activity, performance or events and circumstances reflected in the
forward-looking statements will be achieved or occur. These
forward-looking statements speak only as of the date of this
Quarterly Report on Form 10-Q and are subject to a number of risks,
uncertainties and assumptions described in Item 1A. “Risk Factors.”
Because forward-looking statements are inherently subject to risks
and uncertainties, some of which cannot be predicted or quantified,
you should not rely on these forward-looking statements as
predictions of future events. 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. Some of the key
factors that could cause actual results to differ from our
expectations include:
•
the potential impacts of raising additional capital, including
dilution to our existing stockholders, restrictions on our
operations or requirements that we relinquish rights to our
technologies or product candidates;
•
business interruptions resulting from the coronavirus disease
(“COVID-19”) outbreak or similar public health crises, which could
cause a disruption to the development of our product candidates and
adversely impact our business;
•
the success, cost, and duration of our product development
activities and clinical trials;
•
the timing of our planned regulatory submissions to the FDA for our
bezuclastinib product candidate, also known as
CGT9486;
•
our ability to obtain and maintain regulatory approval for our
bezuclastinib product candidate and any other product candidates we
may develop, and any related restrictions, limitations, and/or
warnings in the label of an approved product
candidate;
•
the potential for our identified research priorities to advance our
bezuclastinib product candidate or for our teams to discover and
develop additional product candidates;
•
the ability to license additional intellectual property rights
relating to our bezuclastinib product candidate or future product
candidates from third-parties and to comply with our existing or
future license agreements and/or collaboration
agreements;
•
our ability to commercialize our bezuclastinib product candidate
and future product candidates in light of the intellectual property
rights of others;
•
our ability to obtain funding for our operations, including funding
necessary to complete further discovery, development and
commercialization of our existing and future product
candidates;
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the scalability and commercial viability of our manufacturing
methods and processes;
•
the commercialization of our product candidates, if
approved;
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our ability to attract collaborators with development, regulatory,
and commercialization expertise;
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future agreements with third parties in connection with the
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;
•
the pricing and reimbursement of our product candidates, if
approved;
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regulatory developments in the United States and foreign
countries;
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our ability to contract with third-party suppliers and
manufacturers and their ability to perform adequately;
•
the development and success of competing therapies that are or may
be under development in clinical trials or become available
commercially;
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our ability to attract and retain key scientific and management
personnel;
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the accuracy of our estimates regarding expenses, future revenue,
capital requirements, and needs for additional
financing;
•
our use of the proceeds from the private placements, sales of our
preferred stock and public offerings of our common stock from time
to time; and
ii
•
our expectations regarding our ability to obtain and maintain
intellectual property protection for our bezuclastinib product
candidate and future product candidates.
While we may elect to update these forward-looking statements at
some point in the future, whether as a result of any new
information, future events, or otherwise, we have no current
intention of doing so except to the extent required by applicable
law.
iii
Cogent Biosciences, Inc.
Table of Contents
iv
PART I—FINANCIAL
INFORMATION
Item 1. Financial Statements
(Unaudited)
COGENT BIOSCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE
SHEETS
(in thousands, except share and per share amounts)
(unaudited)
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September 30,
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December 31,
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2022
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2021
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Assets
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Current assets:
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Cash and cash equivalents
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$
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140,568
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$
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219,684
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Marketable securities
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148,526
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$
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—
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Prepaid expenses and other current assets
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|
|
6,068
|
|
|
|
2,949
|
|
|
Restricted cash
|
|
|
1,255
|
|
|
|
—
|
|
|
Total current assets
|
|
|
296,417
|
|
|
|
222,633
|
|
|
Operating lease, right-of-use asset
|
|
|
23,832
|
|
|
|
2,771
|
|
|
Property and equipment, net
|
|
|
6,543
|
|
|
|
1,706
|
|
|
Restricted cash
|
|
|
—
|
|
|
|
1,255
|
|
|
Other assets
|
|
|
4,768
|
|
|
|
3,727
|
|
|
Total assets
|
|
$
|
331,560
|
|
|
$
|
232,092
|
|
|
Liabilities and Stockholders’ Equity
|
|
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
4,093
|
|
|
$
|
3,483
|
|
|
Accrued expenses and other current liabilities
|
|
|
14,384
|
|
|
|
8,210
|
|
|
CVR liability (Note 3)
|
|
|
3,060
|
|
|
|
3,060
|
|
|
Operating lease liability
|
|
|
2,014
|
|
|
|
2,324
|
|
|
Total current liabilities
|
|
|
23,551
|
|
|
|
17,077
|
|
|
Operating lease liability, net of current portion
|
|
|
18,067
|
|
|
|
831
|
|
|
Total liabilities
|
|
|
41,618
|
|
|
|
17,908
|
|
|
Commitments and
contingencies (Note
7)
|
|
|
|
|
|
|
|
Stockholders’ equity:
|
|
|
|
|
|
|
|
Preferred stock, $0.001 par
value;
9,000,000 shares
authorized;
no shares
issued
or outstanding
|
|
|
—
|
|
|
|
—
|
|
|
Series A non-voting convertible preferred stock,
$0.001 par
value;
1,000,000
shares authorized;
81,050 and
103,289 shares
issued and outstanding at
September 30, 2022 and December 31, 2021,
respectively
|
|
|
65,830
|
|
|
|
85,400
|
|
|
Common stock, $0.001 par
value;
150,000,000 shares
authorized;
69,857,972
shares and
43,805,922 shares
issued and outstanding at September 30, 2022 and
December 31, 2021, respectively
|
|
|
70
|
|
|
|
44
|
|
|
Additional paid-in capital
|
|
|
595,801
|
|
|
|
399,713
|
|
|
Accumulated other comprehensive loss
|
|
|
(163
|
)
|
|
|
—
|
|
|
Accumulated deficit
|
|
|
(371,596
|
)
|
|
|
(270,973
|
)
|
|
Total stockholders’ equity
|
|
|
289,942
|
|
|
|
214,184
|
|
|
Total liabilities and stockholders’ equity
|
|
$
|
331,560
|
|
|
$
|
232,092
|
|
The accompanying notes are an integral part of these condensed
consolidated financial statements.
1
COGENT BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS
(in thousands, except share and per share amounts)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30,
|
|
|
Nine Months Ended September 30,
|
|
|
|
2022
|
|
|
2021
|
|
|
2022
|
|
|
2021
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
29,936
|
|
|
|
14,798
|
|
|
|
84,885
|
|
|
|
35,399
|
|
|
General and administrative
|
|
6,885
|
|
|
|
5,021
|
|
|
|
19,209
|
|
|
|
14,512
|
|
|
Total operating expenses
|
|
36,821
|
|
|
|
19,819
|
|
|
|
104,094
|
|
|
|
49,911
|
|
|
Loss from operations
|
|
(36,821
|
)
|
|
|
(19,819
|
)
|
|
|
(104,094
|
)
|
|
|
(49,911
|
)
|
|
Other income:
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
1,500
|
|
|
|
115
|
|
|
|
1,879
|
|
|
|
360
|
|
|
Other income, net
|
|
259
|
|
|
|
620
|
|
|
|
1,592
|
|
|
|
1,847
|
|
|
Change in fair value of CVR liability
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
343
|
|
|
Total other income, net
|
|
1,759
|
|
|
|
735
|
|
|
|
3,471
|
|
|
|
2,550
|
|
|
Net loss
|
$
|
(35,062
|
)
|
|
$
|
(19,084
|
)
|
|
$
|
(100,623
|
)
|
|
$
|
(47,361
|
)
|
|
Net loss per share attributable to common stockholders, basic and
diluted
|
$
|
(0.50
|
)
|
|
$
|
(0.48
|
)
|
|
$
|
(1.84
|
)
|
|
$
|
(1.25
|
)
|
|
Weighted average common shares outstanding, basic and
diluted
|
|
69,576,359
|
|
|
|
39,848,943
|
|
|
|
54,780,041
|
|
|
|
37,741,526
|
|
|
Comprehensive loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
$
|
(35,062
|
)
|
|
$
|
(19,084
|
)
|
|
$
|
(100,623
|
)
|
|
$
|
(47,361
|
)
|
|
Other comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
Net unrealized losses on marketable securities
|
|
(163
|
)
|
|
|
—
|
|
|
|
(163
|
)
|
|
|
—
|
|
|
Total other comprehensive loss
|
|
(163
|
)
|
|
|
—
|
|
|
|
(163
|
)
|
|
|
—
|
|
|
Comprehensive loss
|
$
|
(35,225
|
)
|
|
$
|
(19,084
|
)
|
|
$
|
(100,786
|
)
|
|
$
|
(47,361
|
)
|
The accompanying notes are an integral part of these condensed
consolidated financial statements.
2
COGENT BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS
OF STOCKHOLDERS’ EQUITY
(in thousands, except share amounts)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series A Non-Voting
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convertible Preferred
Stock
|
|
|
Common Stock
|
|
|
Additional
Paid-in
|
|
|
Accumulated
Other Comprehensive
|
|
|
Accumulated
|
|
|
Total
Stockholders’
|
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Shares
|
|
|
Amount
|
|
|
Capital
|
|
|
Loss
|
|
|
Deficit
|
|
|
Equity
|
|
|
Balances at December 31, 2021
|
|
|
103,289
|
|
|
$
|
85,400
|
|
|
|
43,805,922
|
|
|
$
|
44
|
|
|
$
|
399,713
|
|
|
$
|
—
|
|
|
$
|
(270,973
|
)
|
|
$
|
214,184
|
|
|
Conversion of Series A non-voting preferred
stock into common stock
|
|
|
(7,955
|
)
|
|
|
(7,000
|
)
|
|
|
1,988,750
|
|
|
|
2
|
|
|
|
6,998
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
Issuance of common stock under Employee
Stock Purchase Plan
|
|
|
—
|
|
|
|
—
|
|
|
|
18,995
|
|
|
|
—
|
|
|
|
129
|
|
|
|
—
|
|
|
|
—
|
|
|
|
129
|
|
|
Issuance of common stock upon exercise of
stock options
|
|
|
—
|
|
|
|
—
|
|
|
|
5,599
|
|
|
|
—
|
|
|
|
9
|
|
|
|
—
|
|
|
|
—
|
|
|
|
9
|
|
|
Stock-based compensation expense
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
4,175
|
|
|
|
—
|
|
|
|
—
|
|
|
|
4,175
|
|
|
Net loss
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(30,634
|
)
|
|
|
(30,634
|
)
|
|
Balances at March 31, 2022
|
|
|
95,334
|
|
|
|
78,400
|
|
|
|
45,819,266
|
|
|
|
46
|
|
|
|
411,024
|
|
|
|
—
|
|
|
|
(301,607
|
)
|
|
|
187,863
|
|
|
Issuance of common stock and pre-funded
warrants in underwritten public offering,
net of offering costs of $10.8 million
|
|
|
—
|
|
|
|
—
|
|
|
|
17,899,698
|
|
|
|
18
|
|
|
|
161,897
|
|
|
|
—
|
|
|
|
—
|
|
|
|
161,915
|
|
|
Conversion of Series A non-voting preferred
stock into common stock
|
|
|
(7,955
|
)
|
|
|
(7,000
|
)
|
|
|
1,988,750
|
|
|
|
2
|
|
|
|
6,998
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
Stock-based compensation expense
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
4,534
|
|
|
|
—
|
|
|
|
—
|
|
|
|
4,534
|
|
|
Net loss
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(34,927
|
)
|
|
|
(34,927
|
)
|
|
Balances at June 30, 2022
|
|
|
87,379
|
|
|
|
71,400
|
|
|
|
65,707,714
|
|
|
|
66
|
|
|
|
584,453
|
|
|
|
—
|
|
|
|
(336,534
|
)
|
|
|
319,385
|
|
|
Conversion of Series A non-voting preferred
stock into common stock
|
|
|
(6,329
|
)
|
|
|
(5,570
|
)
|
|
|
1,582,250
|
|
|
|
2
|
|
|
|
5,568
|
|
|
|
—
|
|
|
|
—
|
|
|
$
|
—
|
|
|
Pre-funded warrant exercise
|
|
|
—
|
|
|
|
—
|
|
|
|
2,424,242
|
|
|
|
2
|
|
|
|
22
|
|
|
|
—
|
|
|
|
—
|
|
|
$
|
24
|
|
|
Issuance of common stock under Employee
Stock Purchase Plan
|
|
|
—
|
|
|
|
—
|
|
|
|
30,005
|
|
|
|
—
|
|
|
|
222
|
|
|
|
—
|
|
|
|
—
|
|
|
|
222
|
|
|
Issuance of common stock upon exercise of
stock options
|
|
|
—
|
|
|
|
—
|
|
|
|
113,761
|
|
|
|
—
|
|
|
|
914
|
|
|
|
—
|
|
|
|
—
|
|
|
|
914
|
|
|
Net unrealized losses on marketable securities
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(163
|
)
|
|
|
—
|
|
|
|
(163
|
)
|
|
Stock-based compensation expense
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
4,622
|
|
|
|
—
|
|
|
|
—
|
|
|
|
4,622
|
|
|
Net loss
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(35,062
|
)
|
|
|
(35,062
|
)
|
|
Balances at September 30, 2022
|
|
|
81,050
|
|
|
|
65,830
|
|
|
|
69,857,972
|
|
|
|
70
|
|
|
|
595,801
|
|
|
|
(163
|
)
|
|
|
(371,596
|
)
|
|
|
289,942
|
|
3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series A Non-Voting
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convertible Preferred
Stock
|
|
|
Common Stock
|
|
|
Additional
Paid-in
|
|
|
Accumulated
|
|
|
Total
Stockholders’
|
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Shares
|
|
|
Amount
|
|
|
Capital
|
|
|
Deficit
|
|
|
Equity
|
|
|
Balances at December 31, 2020
|
|
|
132,244
|
|
|
$
|
110,881
|
|
|
|
32,347,905
|
|
|
$
|
32
|
|
|
$
|
322,454
|
|
|
$
|
(198,700
|
)
|
|
$
|
234,667
|
|
|
Conversion of Series A non-voting preferred
stock into common stock
|
|
|
(18,409
|
)
|
|
|
(16,200
|
)
|
|
|
4,602,250
|
|
|
|
5
|
|
|
|
16,195
|
|
|
|
—
|
|
|
|
—
|
|
|
Issuance of common stock to settle CVR
liability
|
|
|
—
|
|
|
|
—
|
|
|
|
212,429
|
|
|
|
—
|
|
|
|
2,043
|
|
|
|
—
|
|
|
|
2,043
|
|
|
Issuance of common stock for services
|
|
|
—
|
|
|
|
—
|
|
|
|
31,683
|
|
|
|
—
|
|
|
|
260
|
|
|
|
—
|
|
|
|
260
|
|
|
Stock-based compensation expense
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
1,521
|
|
|
|
—
|
|
|
|
1,521
|
|
|
Net loss
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(11,728
|
)
|
|
|
(11,728
|
)
|
|
Balances at March 31, 2021
|
|
|
113,835
|
|
|
$
|
94,681
|
|
|
|
37,194,267
|
|
|
$
|
37
|
|
|
$
|
342,473
|
|
|
$
|
(210,428
|
)
|
|
$
|
226,763
|
|
|
Conversion of Series A non-voting preferred
stock into common stock
|
|
|
(10,546
|
)
|
|
|
(9,281
|
)
|
|
|
2,636,500
|
|
|
|
3
|
|
|
|
9,278
|
|
|
|
—
|
|
|
|
—
|
|
|
Stock-based compensation expense
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
2,590
|
|
|
|
—
|
|
|
|
2,590
|
|
|
Net loss
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(16,549
|
)
|
|
|
(16,549
|
)
|
|
Balances at June 30, 2021
|
|
|
103,289
|
|
|
$
|
85,400
|
|
|
|
39,830,767
|
|
|
$
|
40
|
|
|
$
|
354,341
|
|
|
$
|
(226,977
|
)
|
|
$
|
212,804
|
|
|
Issuance of common stock upon exercise of
stock options
|
|
|
—
|
|
|
|
—
|
|
|
|
15,758
|
|
|
|
—
|
|
|
|
24
|
|
|
|
—
|
|
|
|
24
|
|
|
Issuance of common stock under Employee
Stock Purchase Plan
|
|
|
—
|
|
|
|
—
|
|
|
|
4,497
|
|
|
|
—
|
|
|
|
31
|
|
|
|
—
|
|
|
|
31
|
|
|
Stock-based compensation expense
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
3,463
|
|
|
|
—
|
|
|
|
3,463
|
|
|
Net loss
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(19,084
|
)
|
|
|
(19,084
|
)
|
|
Balances at September 30, 2021
|
|
|
103,289
|
|
|
$
|
85,400
|
|
|
|
39,851,022
|
|
|
$
|
40
|
|
|
$
|
357,859
|
|
|
$
|
(246,061
|
)
|
|
$
|
197,238
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these condensed
consolidated financial statements.
4
COGENT BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS
OF CASH FLOWS
(in thousands)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended
September 30,
|
|
|
|
|
2022
|
|
|
2021
|
|
|
Cash flows from operating activities:
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(100,623
|
)
|
|
$
|
(47,361
|
)
|
|
Adjustments to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
Depreciation and amortization expense
|
|
|
422
|
|
|
|
79
|
|
|
Stock-based compensation expense
|
|
|
13,331
|
|
|
|
7,834
|
|
|
Amortization of operating leases, right-of-use assets
|
|
|
4,519
|
|
|
|
1,366
|
|
|
Change in fair value of CVR liability
|
|
|
—
|
|
|
|
(343
|
)
|
|
Net amortization (accretion) of premiums (discounts) on marketable
securities
|
|
|
(456
|
)
|
|
|
—
|
|
|
Right-of-use asset impairment
|
|
|
(396
|
)
|
|
|
—
|
|
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
Prepaid expenses and other current assets
|
|
|
(3,119
|
)
|
|
|
(1,894
|
)
|
|
Other assets
|
|
|
(1,041
|
)
|
|
|
(2,036
|
)
|
|
Accounts payable
|
|
|
610
|
|
|
|
3,617
|
|
|
Accrued expenses and other current liabilities
|
|
|
5,781
|
|
|
|
2,268
|
|
|
Operating lease liability
|
|
|
(8,258
|
)
|
|
|
(1,516
|
)
|
|
Net cash used in operating activities
|
|
|
(89,230
|
)
|
|
|
(37,986
|
)
|
|
Cash flows from investing activities:
|
|
|
|
|
|
|
|
Purchases of property and equipment
|
|
|
(4,896
|
)
|
|
|
(1,286
|
)
|
|
Purchases of marketable securities
|
|
|
(148,233
|
)
|
|
|
—
|
|
|
Net cash used in investing activities
|
|
|
(153,129
|
)
|
|
|
(1,286
|
)
|
|
Cash flows from financing activities:
|
|
|
|
|
|
|
|
Proceeds from issuance of shares of common stock and pre-funded
warrants, net of offering costs of $10.8 million
|
|
|
161,945
|
|
|
|
—
|
|
|
Proceeds from issuance of stock from employee stock purchase
plan
|
|
|
351
|
|
|
|
31
|
|
|
Proceeds from issuance of common stock upon stock option
exercises
|
|
|
923
|
|
|
|
24
|
|
|
Proceeds from pre-funded warrant exercises
|
|
|
24
|
|
|
|
—
|
|
|
Payment to CVR Holders
|
|
|
—
|
|
|
|
(85
|
)
|
|
Net cash (used in) provided by financing activities
|
|
|
163,243
|
|
|
|
(30
|
)
|
|
Net (decrease) increase in cash, cash equivalents and restricted
cash
|
|
|
(79,116
|
)
|
|
|
(39,302
|
)
|
|
Cash, cash equivalents and restricted cash at beginning of
period
|
|
|
220,939
|
|
|
|
243,445
|
|
|
Cash, cash equivalents and restricted cash at end of
period
|
|
$
|
141,823
|
|
|
$
|
204,143
|
|
|
Supplemental disclosure of cash flow information:
|
|
|
|
|
|
|
|
Right-of-use assets obtained in exchange for new operating lease
liabilities
|
|
$
|
25,184
|
|
|
$
|
—
|
|
|
Supplemental disclosure of noncash investing and financing
information:
|
|
|
|
|
|
|
|
Offering costs included in accounts payable and accrued
expenses
|
|
$
|
30
|
|
|
$
|
—
|
|
|
Property & equipment included in accounts payable and accrued
expenses
|
|
$
|
363
|
|
|
$
|
—
|
|
|
Conversion of Series A Convertible Preferred stock into common
shares
|
|
$
|
19,570
|
|
|
$
|
25,481
|
|
|
Issuance of shares in partial settlement of CVR
liability
|
|
$
|
—
|
|
|
$
|
2,043
|
|
The accompanying notes are an integral part of these condensed
consolidated financial statements.
5
COGENT BIOSCIENCES, INC.
NOTES TO CONDENSED CONSOLIDATED
FINANCIAL STATEMENTS
(unaudited)
1.
Nature of the Business and Basis of Presentation
Cogent Biosciences, Inc. (“Cogent” or the “Company”) is a
biotechnology company focused on developing precision therapies for
genetically defined diseases. Cogent’s approach is to design
rational precision therapies that treat the underlying cause of
disease and improve the lives of patients. Cogent’s most advanced
program is bezuclastinib, also known as CGT9486, a highly selective
tyrosine kinase inhibitor designed to potently inhibit the KIT
D816V mutation as well as other mutations in KIT exon 17. In the
vast majority of cases, KIT D816V is responsible for driving
Systemic Mastocytosis (“SM”), a serious disease caused by unchecked
proliferation of mast cells. Exon 17 mutations are also found in
patients with advanced gastrointestinal stromal tumors (“GIST”), a
type of cancer with strong dependence on oncogenic KIT signaling.
Bezuclast