Item 1. Financial Statements
Item 1. Financial Statements.
PRAXIS PRECISION MEDICINES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
(Amounts in
thousands, except share and per share data)
September 30,
2020
December 31,
2019
Assets
Current assets:
Cash and cash equivalents
$
114,772
$
44,815
Prepaid expenses and other current assets
1,079
681
Total current assets
115,851
45,496
Property and equipment, net
98
128
Restricted cash
600
600
Operating lease
right-of-use assets
933
1,450
Other assets
2,066
20
Total assets
$
119,548
$
47,694
Liabilities, redeemable convertible preferred stock and stockholders deficit
Current liabilities:
Accounts payable
$
3,452
$
2,667
Accrued expenses
6,186
3,455
Operating lease liabilities
746
696
Total current liabilities
10,384
6,818
Long-term liabilities:
Non-current portion of operating lease
liabilities
198
763
Total liabilities
10,582
7,581
Commitments and contingencies (Note 5)
Series A redeemable convertible preferred stock, $0.0001 par value; 8,075,799 shares authorized as
of September 30, 2020 and December 31, 2019; 8,075,799 shares issued and outstanding as of September 30, 2020 and December 31, 2019; liquidation value as of September 30, 2020 and December 31, 2019 of $10,416 and
$9,932, respectively
10,416
9,932
Series B redeemable convertible preferred stock, $0.0001 par value; 14,913,704 shares authorized
as of September 30, 2020 and December 31, 2019; 14,913,704 shares issued and outstanding as of September 30, 2020 and December 31, 2019; liquidation value as of September 30, 2020 and December 31, 2019 of $52,648 and
$49,969, respectively
52,648
49,969
Series B-1 redeemable convertible preferred stock, $0.0001
par value; 2,666,666 shares authorized as of September 30, 2020 and December 31, 2019; 2,666,666 shares issued and outstanding as of September 30, 2020 and December 31, 2019; liquidation value as of September 30, 2020 and
December 31, 2019 of $11,029 and $10,431, respectively
11,029
10,431
Series C redeemable convertible preferred stock, $0.0001 par value; 8,543,692 shares authorized as
of September 30, 2020 and 11,067,963 shares authorized as of December 31, 2019; 8,543,692 shares issued and outstanding as of September 30, 2020 and 9,805,827 shares issued and outstanding as of December 31, 2019; liquidation
value as of September 30, 2020 and December 31, 2019 of $46,244 and $50,789, respectively
46,244
50,789
Series C-1 redeemable convertible preferred stock, $0.0001
par value; 19,444,453 shares authorized as of September 30, 2020 and no shares authorized as of December 31, 2019; 19,444,453 shares issued and outstanding as of September 30, 2020 and no shares issued and outstanding as of
December 31, 2019; liquidation value as of September 30, 2020 and December 31, 2019 of $111,892 and $0, respectively
111,892
Stockholders deficit:
Common stock, $0.0001 par value; 70,500,000 shares authorized as of September 30, 2020 and
46,000,000 shares authorized as of December 31, 2019; 1,681,698 shares issued and 1,672,935 shares outstanding as of September 30, 2020 and 1,670,070 shares issued and 1,621,880 shares outstanding as of December 31, 2019
1
1
Accumulated deficit
(123,264
)
(81,009
)
Total stockholders deficit
(123,263
)
(81,008
)
Total liabilities, redeemable convertible preferred stock and stockholders deficit
$
119,548
$
47,694
The accompanying notes are an integral part of these condensed consolidated financial statements.
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PRAXIS PRECISION MEDICINES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
(Amounts in
thousands, except share and per share data)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2020
2019
2020
2019
Operating expenses:
Research and development
$
12,786
$
9,346
$
28,704
$
23,858
General and administrative
3,431
1,308
7,552
4,437
Total operating expenses
16,217
10,654
36,256
28,295
Loss from operations
(16,217
)
(10,654
)
(36,256
)
(28,295
)
Other income:
Interest income
1
48
134
171
Total other income
1
48
134
171
Loss before benefit from income taxes
(16,216
)
(10,606
)
(36,122
)
(28,124
)
Benefit from income taxes
(8
)
Net loss and comprehensive loss
$
(16,216
)
$
(10,606
)
$
(36,114
)
$
(28,124
)
Accretion and cumulative dividends on redeemable convertible preferred stock
(3,943
)
(1,267
)
(8,046
)
(3,450
)
Gain on repurchase of redeemable convertible preferred stock
493
Net loss attributable to common stockholders
$
(20,159
)
$
(11,873
)
$
(43,667
)
$
(31,574
)
Net loss per share attributable to common stockholders, basic and diluted
$
(12.10
)
$
(7.61
)
$
(26.53
)
$
(21.02
)
Weighted average common shares outstanding, basic and diluted
1,665,902
1,559,800
1,645,982
1,501,908
The accompanying notes are an integral part of these condensed consolidated financial statements.
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PRAXIS PRECISION MEDICINES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS DEFICIT
(Unaudited)
(Amounts in
thousands, except share data)
Three Months Ended
Series A
Redeemable
Convertible
Preferred Stock
Series B
Redeemable
Convertible
Preferred Stock
Series B-1
Redeemable
Convertible
Preferred Stock
Series C
Redeemable
Convertible
Preferred Stock
Series C-1
Redeemable
Convertible
Preferred Stock
Common Stock
Additional
Paid-In
Capital
Accumulated
Deficit
Total
Stockholders
Deficit
Shares
Amount
Shares
Amount
Shares
Amount
Shares
Amount
Shares
Amount
Shares
Amount
Balance at June 30, 2020
8,075,799
$
10,254
14,913,704
$
51,749
2,666,666
$
10,828
8,543,692
$
45,359
$
1,648,165
$
1
$
$
(104,085
)
$
(104,084
)
Issuance of Series C-1 redeemable convertible preferred
stock, net of issuance costs of $154
19,444,453
110,096
Stock-based compensation expense
953
953
Issuance of common stock upon exercise of stock options
11,628
27
27
Accretion of redeemable convertible preferred stock to redemption value
162
899
201
885
1,796
(980
)
(2,963
)
(3,943
)
Vesting of restricted stock awards
13,142
Net loss
(16,216
)
(16,216
)
Balance at September 30, 2020
8,075,799
$
10,416
14,913,704
$
52,648
2,666,666
$
11,029
8,543,692
$
46,244
19,444,453
$
111,892
1,672,935
$
1
$
$
(123,264
)
$
(123,263
)
Balance at June 30, 2019
8,075,799
$
9,606
14,913,704
$
48,164
2,666,666
$
10,027
$
$
1,525,500
$
1
$
$
(60,461
)
$
(60,460
)
Stock-based compensation expense
276
276
Accretion of redeemable convertible preferred stock to redemption value
163
902
202
(276
)
(991
)
(1,267
)
Vesting of restricted stock awards
58,410
Net loss
(10,606
)
(10,606
)
Balance at September 30, 2019
8,075,799
$
9,769
14,913,704
$
49,066
2,666,666
$
10,229
$
$
1,583,910
$
1
$
$
(72,058
)
$
(72,057
)
The accompanying notes are an integral part of these condensed consolidated financial statements.
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PRAXIS PRECISION MEDICINES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS DEFICIT
(Unaudited)
(Amounts in
thousands, except share data)
Nine Months Ended
Series A
Redeemable
Convertible
Preferred Stock
Series B
Redeemable
Convertible
Preferred Stock
Series B-1
Redeemable
Convertible
Preferred Stock
Series C
Redeemable
Convertible
Preferred Stock
Series C-1
Redeemable
Convertible
Preferred Stock
Common Stock
Additional
Paid-In
Capital
Accumulated
Deficit
Total
Stockholders
Deficit
Shares
Amount
Shares
Amount
Shares
Amount
Shares
Amount
Shares
Amount
Shares
Amount
Balance at December 31, 2019
8,075,799
$
9,932
14,913,704
$
49,969
2,666,666
$
10,431
9,805,827
$
50,789
$
1,621,880
$
1
$
$
(81,009
)
$
(81,008
)
Repurchase of Series C redeemable convertible preferred stock
(5,825,243
)
(30,493
)
493
493
Issuance of Series C redeemable convertible preferred stock, net of issuance costs of $41
4,563,108
23,459
Issuance of Series C-1 redeemable convertible preferred
stock, net of issuance costs of $154
19,444,453
110,096
Stock-based compensation expense
1,385
1,385
Issuance of common stock upon exercise of stock options
11,628
27
27
Accretion of redeemable convertible preferred stock to redemption value
484
2,679
598
2,489
1,796
(1,412
)
(6,634
)
(8,046
)
Vesting of restricted stock awards
39,427
Net loss
(36,114
)
(36,114
)
Balance at September 30, 2020
8,075,799
$
10,416
14,913,704
$
52,648
2,666,666
$
11,029
8,543,692
$
46,244
19,444,453
$
111,892
1,672,935
$
1
$
$
(123,264
)
$
(123,263
)
Balance at December 31, 2018
8,075,799
$
9,284
14,913,704
$
46,436
$
$
$
1,408,677
$
1
$
326
$
(41,365
)
$
(41,038
)
Issuance of Series B-1 redeemable convertible preferred
stock, net of issuance costs of $61
2,666,666
9,939
Stock-based compensation expense
510
510
Accretion of redeemable convertible preferred stock to redemption value
485
2,630
290
(836
)
(2,569
)
(3,405
)
Vesting of restricted stock awards
175,233
Net loss
(28,124
)
(28,124
)
Balance at September 30, 2019
8,075,799
$
9,769
14,913,704
$
49,066
2,666,666
$
10,229
$
$
1,583,910
$
1
$
$
(72,058
)
$
(72,057
)
The accompanying notes are an integral part of these condensed consolidated financial statements.
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PRAXIS PRECISION MEDICINES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(Amounts in
thousands)
Nine Months Ended
September 30,
2020
2019
Cash flows from operating activities:
Net loss
$
(36,114
)
$
(28,124
)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation expense
30
27
Stock-based compensation expense
1,385
510
Non-cash operating lease expense
517
477
Changes in operating assets and liabilities:
Prepaid expenses and other current assets
(398
)
829
Accounts payable
544
(356
)
Accrued expenses
2,160
3,664
Operating lease liabilities
(515
)
(468
)
Other
(4
)
(25
)
Net cash used in operating activities
(32,395
)
(23,466
)
Cash flows from investing activities:
Purchases of property and equipment
(103
)
Net cash used in investing activities
(103
)
Cash flows from financing activities:
Proceeds from issuance of redeemable convertible preferred stock, net of issuance costs
133,442
9,939
Repurchase of Series C redeemable convertible preferred stock
(30,000
)
Payment of deferred offering costs
(1,117
)
Proceeds from exercise of options to purchase common stock
27
Net cash provided by financing activities
102,352
9,939
Increase (decrease) in cash, cash equivalents and restricted cash
69,957
(13,630
)
Cash, cash equivalents and restricted cash, beginning of period
45,415
18,550
Cash, cash equivalents and restricted cash, end of period
$
115,372
$
4,920
Supplemental disclosures of non-cash
activities:
Accretion of redeemable convertible preferred stock to redemption value
$
8,046
$
3,405
Operating lease liabilities recorded upon adoption of ASC 842
$
$
2,092
Deferred offering costs included in accounts payable and accrued expenses
$
925
$
The accompanying notes are an integral part of these condensed consolidated financial statements.
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PRAXIS PRECISION MEDICINES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
1. Nature of the Business
Praxis Precision Medicines, Inc. (Praxis or the Company) is a clinical-stage biopharmaceutical company
translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal imbalance. The Company has established a broad portfolio, including five disclosed programs across
multiple CNS disorders, including depression, epilepsy, movement disorders and pain syndromes, with three clinical-stage product candidates. The Companys most advanced programs, PRAX-114 and PRAX-944, are currently in Phase 2 development. PRAX-114 is being developed for the treatment of major depressive disorder and perimenopausal depression, and PRAX-944 is a selective small molecule inhibitor of T-type calcium channels for the treatment of essential tremor. The Company plans to continue to discover and develop
additional product candidates and expand into additional therapeutic areas.
Praxis was incorporated in 2015 and commenced operations in
2016. The Company has funded its operations primarily with proceeds from the issuance of convertible debt, Series A redeemable convertible preferred stock (the Series A Preferred Stock), Series B redeemable convertible preferred stock
(the Series B Preferred Stock), Series B-1 redeemable convertible preferred stock (the Series B-1 Preferred Stock), Series C redeemable
convertible preferred stock (the Series C Preferred Stock) and Series C-1 redeemable convertible preferred stock (the Series C-1 Preferred Stock)
(the Series A Preferred Stock, Series B Preferred Stock, Series B-1 Preferred Stock, Series C Preferred Stock and Series C-1 Preferred Stock are collectively referred to
as the Preferred Stock). From inception through September 30, 2020, the Company raised $210.7 million in aggregate cash proceeds from these transactions, net of issuance costs.
On October 8, 2020, the board of directors and the Companys stockholders approved a one-for-2.14 reverse stock split. Effective on October 8, 2020, the reverse stock split impacted the Companys issued and outstanding shares of common stock. Stockholders entitled to fractional
shares as a result of the reverse stock split will receive a cash payment in lieu of receiving fractional shares. All shares of common stock, per share amounts, aggregate par value and additional paid-in
capital amounts for all periods presented in the accompanying condensed consolidated financial statements and related notes have been retroactively adjusted, where applicable, to reflect the reverse stock split. Shares of common stock underlying
outstanding stock options and other equity instruments were proportionately reduced and the respective exercise prices were proportionately increased, as applicable, in accordance with the terms of the agreements governing such securities. The
respective conversion prices of the Preferred Stock were proportionately increased. The number of shares of common stock authorized for issuance and the per share par value of common stock were not adjusted as a result of the reverse stock split.
On October 20, 2020, the Company completed its initial public offering (IPO), in which the Company issued and sold
11,500,000 shares of its common stock at a public offering price of $19.00 per share, including 1,500,000 shares of common stock sold pursuant to the underwriters exercise of their option to purchase additional shares of common stock, for
aggregate gross proceeds of $218.5 million. The Company raised approximately $199.9 million in net proceeds after deducting underwriting discounts and commissions and offering expenses payable by the Company. Upon the closing of the IPO,
all of the outstanding shares of the Companys Preferred Stock automatically converted into 25,067,977 shares of common stock. On October 20, 2020, in connection with the closing of the IPO, the Company filed its Amended and Restated
Certificate of Incorporation which provides that the authorized capital stock of the Company consists of 150,000,000 shares of common stock and 10,000,000 shares of undesignated preferred stock, both with a par value of $0.0001 per share.
The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including but not limited to,
risks associated with completing preclinical studies and clinical trials, receiving regulatory approvals for product candidates, development by competitors of new biopharmaceutical products, dependence on key personnel, protection of proprietary
technology, compliance with government regulations and the ability to secure additional capital to fund operations. Programs currently under development will require significant additional research and development efforts, including preclinical and
clinical testing and regulatory approval, prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel and infrastructure and extensive compliance-reporting capabilities. Even if the Companys
product development efforts are successful, it is uncertain when, if ever, the Company will realize revenue from product sales.
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Liquidity
In accordance with the Financial Accounting Standards Board (FASB) Accounting Standards Update (ASU) 2014-15, Disclosure of Uncertainties about an Entitys Ability to Continue as a Going Concern (Subtopic 205-40) , the Company has evaluated whether there are
conditions and events, considered in the aggregate, that raise substantial doubt about the Companys ability to continue as a going concern within one year after the date that these condensed consolidated financial statements are issued.
The Company has incurred recurring losses since its inception, including net losses of $36.1 million and $28.1 million for the nine
months ended September 30, 2020 and 2019, respectively. In addition, as of September 30, 2020, the Company had an accumulated deficit of $123.3 million. The Company expects to continue to generate operating losses for the foreseeable
future.
The Company previously identified conditions and events that raised substantial doubt about its ability to continue as a going
concern. As a result of the completion of its IPO, the Company expects that its cash and cash equivalents as of September 30, 2020 of $114.8 million, in addition to the net proceeds of $199.9 million from its IPO, will be sufficient
to fund the operating expenses and capital expenditure requirements necessary to advance its research efforts and clinical trials for at least one year from the date of issuance of these condensed consolidated financial statements. The future
viability of the Company is dependent on its ability to raise additional capital to finance its operations. The Companys inability to raise capital as and when needed could have a negative impact on its financial condition and ability to
pursue its business strategies. There can be no assurance that the current operating plan will be achieved or that additional funding will be available on terms acceptable to the Company, or at all.
2. Summary of Significant Accounting Policies
Basis of Presentation
The
accompanying condensed consolidated financial statements have been prepared in conformity with generally accepted accounting principles in the United States of America (GAAP). Any reference in these notes to applicable guidance is meant
to refer to the authoritative GAAP as found in the Accounting Standards Codification (ASC) and ASUs of the FASB.
The
Companys significant accounting policies are disclosed in the audited consolidated financial statements included in the Companys final prospectus filed with the Securities and Exchange Commission (SEC) pursuant to Rule
424(b)(4) on October 16, 2020. Since the date of those audited consolidated financial statements, there have been no changes to the Companys significant accounting policies except as noted below.
Unaudited Interim Condensed Consolidated Financial Information
The accompanying condensed consolidated balance sheet as of September 30, 2020, the condensed consolidated statements of operations and
comprehensive loss for the three and nine months ended September 30, 2020 and 2019, the condensed consolidated statements of cash flows for the nine months ended September 30, 2020 and 2019 and the condensed consolidated statements of
redeemable convertible preferred stock and stockholders deficit for the three and nine months ended September 30, 2020 and 2019 are unaudited. The unaudited interim financial statements have been prepared on the same basis as the audited
annual consolidated financial statements, and in the opinion of management reflect all adjustments, which include only normal recurring adjustments necessary for the fair statement of the Companys financial position as of September 30,
2020, the results of its operations for the three and nine months ended September 30, 2020 and 2019 and its cash flows for the nine months ended September 30, 2020 and 2019. Financial statement disclosures for the three and nine months
ended September 30, 2020 and 2019 are condensed and do not include all disclosures required for an annual set of financial statements in accordance with GAAP.
The results for the three and nine months ended September 30, 2020 are not necessarily indicative of results to be expected for the year
ended December 31, 2020, any other interim periods, or any future year or period.
Use of Estimates
The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions
that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of expenses during the reporting periods.
Significant estimates and assumptions reflected in these condensed consolidated financial statements include, but are not limited to, the accrual for research and development expenses, stock-based compensation expense, and the valuation of equity
awards. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. Actual results could differ materially from those estimates.
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Cash, Cash Equivalents and Restricted Cash
The following table reconciles cash, cash equivalents and restricted cash to the total amounts on the condensed consolidated statements of cash
flows (in thousands):
September 30,
2020
2019
Cash and cash equivalents
$
114,772
$
4,320
Restricted cash
600
600
Total cash, cash equivalents and restricted cash as shown in the condensed consolidated statement
of cash flows
$
115,372
$
4,920
Deferred Offering Costs
The Company capitalizes certain legal, accounting and other third-party fees that are directly associated
with in-process equity financings as deferred offering costs until such financings are consummated. After the consummation of the equity financing, these costs are recorded in stockholders
deficit as a reduction of additional paid-in capital or the associated preferred stock account, as applicable. In the event the offering is terminated, all capitalized deferred offering costs are
expensed. Deferred offering costs as of September 30, 2020 were $2.0 million. Such costs are classified in other assets in the accompanying condensed consolidated balance sheet. No deferred offering costs were capitalized as of
December 31, 2019.
Stock-Based Compensation
The Company utilizes significant estimates and assumptions in determining the fair value of its equity and equity-based awards. Beginning in
the nine months ended September 30, 2020, the Company determined the fair value of shares of its common stock underlying stock-based awards granted using a hybrid probability-weighted expected return method (PWERM). The fair value
of the Companys common stock was calibrated to contemporaneous transactions in the Series C Preferred Stock and Series C-1 Preferred Stock. The hybrid PWERM determined the fair value of the
Companys common stock using a probability-weighted present value of expected future investment returns considering various outcomes, as well as the rights of each class of stock, with one of the outcomes calculated using an option pricing
model (OPM). The hybrid PWERM considered three scenarios: an early IPO completed in 2020, a late IPO completed in 2021, and a remain private scenario in which value is allocated using the OPM. An
incremental discount for lack of marketability (DLOM) was applied to the values of the common stock. The DLOM was estimated using a put option model which considered the expected time to liquidity and the volatility of the common shares.
The hybrid PWERM used a risk-adjusted discount rate.
Other than as noted herein, there were no other changes to the Companys
stock-based compensation policy since the date of the audited consolidated financial statements included in the Companys final prospectus filed pursuant to Rule 424(b)(4) on October 16, 2020.
Comprehensive Loss
Comprehensive
loss includes net loss and certain changes in stockholders deficit that are excluded from net loss. The Companys comprehensive loss was equal to net loss for the three and nine months ended September 30, 2020 and 2019.
Net Loss per Share
The Company
follows the two-class method to compute net loss per share attributable to common stockholders as the Company has issued shares that meet the definition of participating securities. The two-class method determines net income (loss) per share for each class of common and participating securities according to dividends declared or accumulated and participation rights in undistributed earnings. The two-class method requires income (losses) for the period to be allocated between common and participating securities based upon their respective rights to share in the earnings as if all income (losses) for the
period had been distributed. During periods of loss, there is no allocation required under the two-class method since the participating securities do not have a contractual obligation to fund the losses of the
Company.
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Net loss attributable to common stockholders is equal to the net loss for the period, as
adjusted for: (i) cumulative dividends accrued for redeemable convertible preferred stock, whether or not declared, (ii) increases in carrying value recorded for redeemable convertible preferred stock, including accretion on redeemable
convertible preferred stock to redemption value for amounts other than cumulative dividends and (iii) gains on the redemptions of redeemable convertible preferred stock.
Basic net loss per share attributable to common stockholders is computed by dividing the net loss attributable to common stockholders by the
weighted average number of common shares outstanding for the period, which excludes shares of restricted common stock that are not vested. Diluted net loss per share attributable to common stockholders is computed by dividing the net loss
attributable to common stockholders by the weighted average number of common shares outstanding for the period, after giving consideration to the dilutive effect of potentially dilutive common shares. For purposes of this calculation, outstanding
options to purchase shares of common stock, unvested shares of restricted common stock and shares of redeemable convertible preferred stock are considered potentially dilutive common shares. The Company has generated a net loss in all periods
presented so the basic and diluted net loss per share attributable to common stockholders are the same as the inclusion of the potentially dilutive securities would be anti-dilutive.
3. Fair Value of Financial Assets
The
following tables present information about the Companys financial assets measured at fair value on a recurring basis and indicates the level of the fair value hierarchy utilized to determine such fair values (in thousands):
As of September 30, 2020
Level 1
Level 2
Level 3
Total
Assets:
Cash equivalents:
Money market funds
$
114,386
$
$
$
114,386
$
114,386
$
$
$
114,386
As of December 31, 2019
Level 1
Level 2
Level 3
Total
Assets:
Cash equivalents:
Money market funds
$
44,429
$
$
$
44,429
$
44,429
$
$
$
44,429
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4. Accrued Expenses
Accrued expenses consisted of the following (in thousands):
September 30,
2020
December 31,
2019
Accrued external research and development expenses
$
3,370
$
1,552
Accrued personnel-related expenses
1,606
1,059
Accrued license fees
363
Accrued professional services
1,135
110
Accrued other
75
371
Total accrued expenses
$
6,186
$
3,455
5. Commitments and Contingencies
In October 2018, the Company entered into a sublease agreement for office space located in Cambridge, Massachusetts that expires on
December 30, 2021, with no option to renew or terminate early. The base rent increases by approximately 1% annually. The Company issued a letter of credit to the landlord related to the security deposit, secured by restricted cash, which is
reflected as a non-current asset on the accompanying condensed consolidated balance sheets. This lease qualifies as an operating lease.
In January 2019, the Company entered into an arrangement with a third party to sublease a portion of its Cambridge, Massachusetts office
space. This sublease was terminated in November 2019.
6. Redeemable Convertible Preferred Stock
As of September 30, 2020, the authorized capital stock of the Company included 53,644,314 shares of $0.0001 par value Preferred Stock, of
which 8,075,799 shares were designated as Series A Preferred Stock, 14,913,704 shares were designated as Series B Preferred Stock, 2,666,666 shares were designated as Series B-1 Preferred Stock, 8,543,692
shares were designated as Series C Preferred Stock and 19,444,453 shares were designated as Series C-1 Preferred Stock. As of December 31, 2019, the authorized capital stock of the Company included
36,724,132 shares of $0.0001 par value Preferred Stock, of which 8,075,799 shares were designated as Series A Preferred Stock, 14,913,704 shares were designated as Series B Preferred Stock, 2,666,666 shares were designated as Series B-1 Preferred Stock and 11,067,963 shares were designated as Series C Preferred Stock. The rights, preferences and privileges of the Series A Preferred Stock, the Series B Preferred Stock, the Series B-1 Preferred Stock and the Series C Preferred Stock are detailed in the final prospectus filed with the SEC pursuant to Rule 424(b)(4) on October 16, 2020.
On January 20, 2020, the Company granted two investors holding 5,825,243 shares of Series C Preferred Stock that were purchased in
December 2019 the option to put their shares back to the Company at the original issuance price. On February 19, 2020 and March 3, 2020, the investors exercised their put option in full via the execution of Stock Redemption and Release
Agreements in order to effect the repurchase. Pursuant to the Stock Redemption and Release Agreements, the Company agreed to repurchase a total of 5,825,243 shares of Series C Preferred Stock at the original issuance price of $5.15 per share, for an
aggregate cash repurchase price of $30.0 million. Under the terms of the Stock Redemption and Release Agreements, the investors waived their right to cumulative dividends that had accumulated from the original issuance date through the date of
repurchase. The 5,825,243 shares of Series C Preferred Stock were retired upon repurchase, and subsequently authorized for reissuance pursuant to a waiver to the Companys Amended and Restated Certificate of Incorporation entered into by the
Company and the holders of the Preferred Stock.
The Company determined that the additional put right that was granted to the investors
represented a modification of the affected shares of Series C Preferred Stock, but that it did not result in incremental value to the shareholders. As there was no incremental value associated with the modification, there was no impact to the
accounting for the Series C Preferred Stock. The Company also determined that the put right did not require bifurcation, as it does not contain the characteristics of a derivative instrument. Further, the Company determined that the shares of Series
C Preferred Stock that were subject to repurchase did not become mandatorily redeemable until the execution of the Stock Redemption and Release Agreements because the parties did not have an unconditional legal obligation to complete the redemptions
until the associated agreements were finalized. Such determination was made in consultation with legal counsel. Accordingly, the Company recorded each of the redemptions on the respective date of repurchase and recognized a gain on repurchase equal
to the difference between the repurchase price and the carrying value of the Series C Preferred Stock on the respective date of repurchase. The aggregate gain of $0.5 million was recorded upon repurchase as an adjustment to accumulated deficit
in the statement of redeemable convertible preferred stock and stockholders deficit. The gain relates exclusively to the dividends accrued on the repurchased shares, which were waived by the investors as part of the Stock Redemption and
Release Agreements.
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On April 15, 2020 and May 8, 2020, the Company completed additional closings for
the sale and issuance of its Series C Preferred Stock for a total of 4,563,108 shares at $5.15 per share for aggregate cash proceeds of $23.5 million, less an immaterial amount of issuance costs.
On July 24, 2020, the Company entered into the Series C-1 Preferred Stock Purchase Agreement,
which authorized the sale and issuance of up to 19,444,453 shares of its Series C-1 Preferred Stock at a purchase price of $5.67 per share. During the nine months ended September 30, 2020, the Company
issued all 19,444,453 shares of Series C-1 Preferred Stock for gross cash proceeds of $110.3 million, and incurred issuance costs of approximately $0.2 million. Although there were multiple closings
of the Series C-1 Preferred Stock, there was no obligation under the initial closing for investors to purchase, or for the Company to sell to such investors, additional shares of Series C-1 Preferred Stock. The holders of the Series C-1 Preferred Stock are entitled to accrue dividends at an annual rate of $0.4536 per share. Except for the original issuance
price and cumulative dividend accrual rate, the terms of the Series C-1 Preferred Stock are substantially the same as the terms of the Series C Preferred Stock. The issuance of the Series C-1 Preferred Stock resulted in changes to certain rights, preferences and privileges of the Series A Preferred Stock, the Series B Preferred Stock, the Series B-1 Preferred
Stock and the Series C Preferred Stock. The Company concluded that such changes were not significant and resulted in a modification, rather than an extinguishment, of the previously outstanding Preferred Stock. The changes to the terms of the Series
A Preferred Stock, the Series B Preferred Stock, the Series B-1 Preferred Stock and the Series C Preferred Stock did not result in incremental value to the shareholders, and therefore there was no impact to
the accounting for the previously outstanding Preferred Stock.
The Preferred Stock consisted of the following (in thousands, except share
amounts):
As of September 30, 2020
Shares
Authorized
Preferred
Stock Issued
and
Outstanding
Carrying
Value
Liquidation
Preference
Redemption
Value
Common
Stock
Issuable
Upon
Conversion
Series A Preferred Stock
8,075,799
8,075,799
$
10,416
$
10,416
$
10,416
3,773,820
Series B Preferred Stock
14,913,704
14,913,704
52,648
52,648
52,648
6,969,173
Series B-1 Preferred Stock
2,666,666
2,666,666
11,029
11,029
11,029
1,246,133
Series C Preferred Stock
8,543,692
8,543,692
46,244
46,244
46,244
3,992,463
Series C-1 Preferred Stock
19,444,453
19,444,453
111,892
111,892
111,892
9,086,388
53,644,314
53,644,314
$
232,229
$
232,229
$
232,229
25,067,977
As of December 31, 2019
Shares
Authorized
Preferred
Stock Issued
and
Outstanding
Carrying
Value
Liquidation
Preference
Redemption
Value
Common
Stock
Issuable
Upon
Conversion
Series A Preferred Stock
8,075,799
8,075,799
$
9,932
$
9,932
$
9,932
3,773,820
Series B Preferred Stock
14,913,704
14,913,704
49,969
49,969
49,969
6,969,173
Series B-1 Preferred Stock
2,666,666
2,666,666
10,431
10,431
10,431
1,246,133
Series C Preferred Stock
11,067,963
9,805,827
50,789
50,789
50,789
4,582,257
36,724,132
35,461,996
$
121,121
$
121,121
$
121,121
16,571,383
Common stock issuable upon conversion in the tables above represents shares of common stock issuable upon an
automatic conversion in the event of a qualified public offering, pursuant to the Companys Amended and Restated Certificate of Incorporation. As of September 30, 2020, the applicable conversion price for the Series A Preferred Stock,
Series B Preferred Stock, Series B-1 Preferred Stock, Series C Preferred Stock and Series C-1 Preferred Stock was equal to $2.14, $6.42, $8.03, $11.02 and $12.13,
respectively, as adjusted for the Companys reverse stock split.
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The Companys cumulative dividends on its Preferred Stock were as follows (in
thousands):
As of September 30,
2020
As of December 31,
2019
Series A Preferred Stock
$
2,340
$
1,857
Series B Preferred Stock
7,907
5,228
Series B-1 Preferred Stock
1,029
431
Series C Preferred Stock
2,244
289
Series C-1 Preferred Stock
1,642
$
15,162
$
7,805
7. Common Stock
As of September 30, 2020 and December 31, 2019, the authorized capital stock of the Company included 70,500,000 and 46,000,000 shares
of common stock, $0.0001 par value, respectively.
Shares Reserved for Future Issuance
The Company has reserved the following shares of common stock for future issuance:
September 30,
2020
December 31,
2019
Series A Preferred Stock
3,773,820
3,773,820
Series B Preferred Stock
6,969,173
6,969,173
Series B-1 Preferred Stock
1,246,133
1,246,133
Series C Preferred Stock
3,992,463
4,582,257
Series C-1 Preferred Stock
9,086,388
Shares reserved for vesting of restricted common stock
8,763
48,190
Shares reserved for exercise of outstanding stock options
5,814,944
1,634,686
Shares reserved for future awards under the 2017 Stock Incentive Plan
6,051
617,101
Total shares of authorized common stock reserved for future issuance
30,897,735
18,871,360
8. Stock-Based Compensation
2017 Stock Incentive Plan
The
total number of shares of common stock authorized for issuance under the 2017 Stock Incentive Plan (the 2017 Plan) as of September 30, 2020 and December 31, 2019 was 5,937,763 shares and 2,356,927 shares, respectively. As of
September 30, 2020, the Company did not hold any treasury shares.
Restricted Common Stock
The following table summarizes all of the Companys restricted common stock activity:
Shares
Weighted
Average
Grant Date
Fair Value
Unvested as of December 31, 2019
48,190
$
0.06
Issued
Vested
(39,427
)
0.05
Repurchased
Unvested as of September 30, 2020
8,763
$
0.08
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The total fair value of restricted common stock that vested during the three months ended
September 30, 2020 and 2019 was $0.1 million and $0.2 million, respectively. The total fair value of restricted common stock that vested during the nine months ended September 30, 2020 and 2019 was $0.2 million and
$0.5 million, respectively.
Stock Options
The following table summarizes the Companys stock option activity:
Number of
Shares
Weighted
Average
Exercise Price
per Share
Weighted
Average
Remaining
Contractual
Term
Aggregate
Intrinsic Value
(In years)
(In thousands)
Outstanding as of December 31, 2019
1,634,686
$
2.46
Granted
4,295,618
7.54
Exercised
(11,628
)
2.32
$
40
Cancelled or Forfeited
(103,732
)
3.26
Outstanding as of September 30, 2020
5,814,944
$
6.20
9.41
$
15,761
Exercisable as of September 30, 2020
959,256
$
2.29
8.10
$
6,350
Vested and expected to vest as of September 30, 2020
5,814,944
$
6.20
9.41
$
15,761
The aggregate intrinsic value of stock options outstanding, exercisable, and vested and expected to vest is
calculated as the difference between the exercise price of the underlying stock options and the estimated fair value of the Companys common stock for those stock options that had exercise prices lower than the estimated fair value of the
Companys common stock at September 30, 2020. The aggregate intrinsic value of stock options exercised is calculated as the difference between the exercise price of the underlying stock options and the estimated fair value of the
Companys common stock on the date of exercise for those stock options that had exercise prices lower than the estimated fair value of the Companys common stock on the exercise date.
Stock Option Valuation
The assumptions
that the Company used in the Black-Scholes option pricing model to determine the grant-date fair value of stock options granted to employees, members of the board of directors and non-employees on the date of
grant were as follows for the three and nine months ended September 30, 2020 and 2019:
Three Months Ended
September 30,
Nine Months Ended
September 30,
2020
2019
2020
2019
Risk-free interest rate
0.37 0.68
%
1.55
%
0.37 0.91
%
1.55
%
Expected term (in years)
6.00 10.00
6.00
6.00 10.00
6.00
Expected volatility
85.74 87.30
%
79.09
%
85.74 88.11
%
79.09
%
Expected dividend yield
0.00
%
0.00
%
0.00
%
0.00
%
Fair value per share of common stock
$
8.27 8.91
$
3.30
$
5.59 8.91
$
3.30
The weighted-average grant-date fair value of the Companys stock options granted during the three months
ended September 30, 2020 and 2019 was $6.30 per share and $2.25 per share, respectively. The weighted-average grant-date fair value of the Companys stock options granted during the nine months ended September 30, 2020 and 2019 was
$5.41 per share and $2.25 per share, respectively.
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Stock-Based Compensation
Stock-based compensation expense was allocated as follows (in thousands):
Three Months Ended
September 30,
Nine Months Ended
September 30,
2020
2019
2020
2019
Research and development
$
384
$
175
$
639
$
316
General and administrative
569
101
746
194
Total stock-based compensation expense
$
953
$
276
$
1,385
$
510
As of September 30, 2020, total unrecognized compensation cost related to unvested stock-based awards was
$23.3 million, which is expected to be recognized over a weighted-average period of 3.74 years.
9. Net Loss per Share
Basic and diluted net loss per share attributable to common stockholders was calculated as follows (in thousands, except share and per share
data):
Three Months Ended
September 30,
Nine Months Ended
September 30,
2020
2019
2020
2019
Numerator:
Net loss
$
(16,216
)
$
(10,606
)
$
(36,114
)
$
(28,124
)
Accretion and cumulative dividends on redeemable convertible preferred stock
(3,943
)
(1,267
)
(8,046
)
(3,450
)
Gain on repurchase of redeemable convertible preferred stock
493
Net loss attributable to common stockholders
$
(20,159
)
$
(11,873
)
$
(43,667
)
$
(31,574
)
Denominator:
Weighted average common shares outstanding, basic and diluted
1,665,902
1,559,800
1,645,982
1,501,908
Net loss per share attributable to common stockholders, basic and diluted
$
(12.10
)
$
(7.61
)
$
(26.53
)
$
(21.02
)
The following potential shares of common stock, presented based on amounts outstanding at each period end,
were excluded from the calculation of diluted net loss per share attributable to common stockholders for the periods indicated because including them would have been anti-dilutive:
Three Months Ended
September 30,
Nine Months Ended
September 30,
2020
2019
2020
2019
Series A Preferred Stock
3,773,820
3,773,820
3,773,820
3,773,820
Series B Preferred Stock
6,969,173
6,969,173
6,969,173
6,969,173
Series B-1 Preferred Stock
1,246,133
1,246,133
1,246,133
1,246,133
Series C Preferred Stock
3,992,463
3,992,463
Series C-1 Preferred Stock
9,086,388
9,086,388
Outstanding stock options
5,814,944
1,634,686
5,814,944
1,634,686
Unvested restricted common stock
8,763
86,160
8,763
86,160
30,891,684
13,709,972
30,891,684
13,709,972
The shares of common stock issuable upon conversion of the Preferred Stock assume automatic conversion in the
event of a qualified public offering.
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10. Related Party Transactions
On September 11, 2019, the Company entered into a Cooperation and License Agreement (the License Agreement) with RogCon Inc.
(RogCon). Under the License Agreement, RogCon granted to the Company an exclusive, worldwide license under RogCons intellectual property to research, develop and commercialize products for the treatment of all forms of epilepsy
and/or neurodevelopmental disorders in each case caused by any mutation of the SCN2A gene. Pursuant to the terms of the License Agreement, the Company will conduct, at its own cost and expense, the research and development activities assigned
to it under the associated research plan. In addition, the Company is responsible for reimbursing RogCon for any costs associated with research and development activities RogCon performs at the request of the Company. One of the founders of RogCon
became the Companys General Counsel in June 2020. The Company continues to reimburse RogCon for its out-of-pocket costs incurred for activities performed under the
License Agreement. During the three months ended September 30, 2020, the Company expensed less than $0.1 million for the reimbursement of RogCons
out-of-pocket costs. During the nine months ended September 30, 2020, the Company expensed $0.1 million for the reimbursement of RogCons out-of-pocket costs. As of September 30, 2020, the Company had accrued expenses of $0.3 million due to RogCon under the License Agreement.
11. Subsequent Events
The Company
considers events or transactions that occur after the balance sheet date but prior to the issuance of the condensed consolidated financial statements to provide additional evidence for certain estimates or to identify matters that require additional
disclosure. In addition to those subsequent events disclosed previously, the Company has identified the following subsequent events:
2020 Stock Option
and Incentive Plan and 2020 Employee Stock Purchase Plan
The Companys 2020 Stock Option and Incentive Plan (the 2020
Plan) and 2020 Employee Stock Purchase Plan (the 2020 ESPP) were adopted by the board of directors on September 9, 2020 and approved by the Companys stockholders on October 8, 2020. Both the 2020 Plan and the 2020
ESPP became effective upon the date immediately preceding the date on which the Companys registration statement filed with the SEC pursuant to Rule 424(b)(4) was declared effective by the SEC, which was October 15, 2020. The 2020 Plan
replaced the 2017 Plan. However, the 2017 Plan will continue to govern outstanding equity awards granted thereunder. Under the 2020 Plan, the Company may make equity-based and cash-based incentive awards to its officers, employees, directors and
consultants. The Company has initially reserved 3,271,028 shares and 327,102 shares of common stock for issuance under the 2020 Plan and the 2020 ESPP, respectively.
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Item 2. Managements Discussion and Analysis of Financial Condition and
Results of Operations.
You should read the following discussion and analysis of our financial condition and results of operations together with our
condensed consolidated financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q and the final prospectus for our initial public offering filed pursuant to Rule 424(b)(4)
under the Securities Act of 1933, as amended, or the Securities Act, with the Securities and Exchange Commission, or SEC, on October 16, 2020. Some of the information contained in this discussion and analysis or set forth elsewhere in this
Quarterly Report on Form 10-Q, including information with respect to our plans and strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties. As
a result of many factors, including those factors set forth in the Risk Factors section of this Quarterly Report on Form 10-Q, our actual results could differ materially from the results described
in or implied by the forward-looking statements contained in the following discussion and analysis.
Overview
We are a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system, or
CNS, disorders characterized by neuronal imbalance. Normal brain function requires a delicate balance of excitation and inhibition in neuronal circuits, which, when dysregulated, leads to abnormal function and disease. We are applying insights into
the genetic mutations that drive excitation-inhibition imbalance in diseases to select biological targets for severe pediatric epilepsies and more broadly for prevalent psychiatric diseases and neurologic disorders. We apply a deliberate and
pragmatic precision approach, leveraging a suite of translational tools including novel transgenic and predictive translational animal models and electrophysiology markers, to enable an efficient path to proof-of-concept in patients. Through this approach, we have established a broad portfolio, including five disclosed programs across multiple CNS disorders, including depression, epilepsy, movement disorders
and pain syndromes, with three clinical-stage product candidates. We expect multiple topline clinical trial readouts from all three programs within the next 18 months and anticipate the launch of a new clinical development program in 2021. We intend
to develop differentiated therapies that can deliver long-term benefits to human health by meaningfully impacting patients and society.
Our most advanced programs, PRAX-114 and PRAX-944, are
currently in Phase 2 development. PRAX-114 is being developed for the treatment of major depressive disorder and perimenopausal depression. Together, these conditions affect more than 22 million patients
in the United States. PRAX-944 is a selective small molecule inhibitor of T-type calcium channels for the treatment of essential tremor, a progressive and debilitating
movement disorder affecting up to seven million people in the United States. In addition, we have initiated a Phase 1 trial of PRAX-562, a persistent sodium current blocker, for the treatment of a broad range
of rare, devastating CNS disorders, such as severe pediatric epilepsy and adult cephalgia. In addition to our clinical programs, we have two disclosed preclinical product candidates in development for severe genetic epilepsies.
We were incorporated in 2015 and commenced operations in 2016. Since inception, we have devoted substantially all of our resources to
developing our preclinical and clinical product candidates, building our intellectual property portfolio, business planning, raising capital and providing general and administrative support for these operations. We employ a virtual
research and development model, relying heavily upon external consultants, collaborators and contract research organizations to conduct our preclinical and clinical activities. Since inception, we have financed our operations primarily with proceeds
from the issuance of convertible debt, sales of our Series A redeemable convertible preferred stock, Series B redeemable convertible preferred stock, Series B-1 redeemable convertible preferred stock, Series C
redeemable convertible preferred stock and Series C-1 redeemable convertible preferred stock and the closing of our initial public offering, or IPO.
On October 20, 2020, we completed our IPO in which we issued and sold 11,500,000 shares of our common stock at a public offering price of
$19.00 per share, including 1,500,000 shares of common stock sold pursuant to the underwriters exercise of their option to purchase additional shares of common stock, for aggregate gross proceeds of $218.5 million. We raised approximately
$199.9 million in net proceeds after deducting underwriting discounts and commissions and offering expenses payable by us. Upon the closing of the IPO, all of the outstanding shares of our Series A redeemable convertible preferred stock, Series
B redeemable convertible preferred stock, Series B-1 redeemable convertible preferred stock, Series C redeemable convertible preferred stock and Series C-1 redeemable
convertible preferred stock automatically converted into 25,067,977 shares of common stock. Subsequent to the closing of the IPO, there were no shares of preferred stock outstanding. In connection with the closing of the IPO, we filed an Amended and
Restated Certificate of Incorporation to change the authorized capital stock to 150,000,000 shares of common stock and 10,000,000 shares of undesignated preferred stock.
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We are a development stage company and we have not generated any revenue from product sales,
and do not expect to do so for several years, if at all. All of our programs are still in preclinical and clinical development. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful
development and eventual commercialization of one or more of our product candidates, if approved. We have incurred recurring operating losses since inception, including a net loss of $36.1 million for the nine months ended September 30,
2020. As of September 30, 2020, we had an accumulated deficit of $123.3 million. We expect to incur significant expenses and operating losses for the foreseeable future as we expand our research and development activities. In addition, our
losses from operations may fluctuate significantly from quarter-to-quarter and
year-to-year, depending on the timing of our clinical trials and our expenditures on other research and development activities. We anticipate that our expenses will
increase significantly in connection with our ongoing activities, as we:
advance our lead product candidates, PRAX-114 and PRAX-944, to late stage clinical trials;
advance our PRAX-562 product candidate to Phase 2 clinical trials;
advance our preclinical programs to clinical trials;
further invest in our pipeline;
further invest in our manufacturing capabilities;
seek regulatory approval for our investigational medicines;
maintain, expand, protect and defend our intellectual property portfolio;
acquire or in-license technology;
secure facilities to support continued growth in our research, development and commercialization efforts;
increase our headcount to support our development efforts and to expand our clinical development team; and
incur additional costs and headcount associated with our transition to becoming a public company.
In addition, as we progress toward marketing approval for any of our product candidates, we expect to incur significant
commercialization expenses related to product manufacturing, marketing, sales and distribution.
As a result, we will need substantial
additional funding to support our continuing operations and pursue our growth strategy. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through the sale of equity, debt
financings or other capital sources, including potential collaborations with other companies or other strategic transactions. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favorable
terms, or at all. If we fail to raise capital or enter into such agreements as, and when, needed, we may have to significantly delay, scale back or discontinue the development and commercialization of one or more of our product candidates or delay
our pursuit of potential in-licenses or acquisitions.
Because of the numerous risks and
uncertainties associated with product development, we are unable to predict the timing or amount of increased expenses or when or if we will be able to achieve or maintain profitability. Even if we are able to generate product sales, we may not
become profitable. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce or terminate our operations.
As of September 30, 2020, we had cash and cash equivalents of $114.8 million. We believe that our existing cash and cash
equivalents, combined with the net proceeds from our IPO, will enable us to fund our operating expenses and capital expenditure requirements into the fourth quarter of 2022. We have based this estimate on assumptions that may prove to be wrong, and
we could exhaust our available capital resources sooner than we expect. See Liquidity and Capital Resources.
COVID-19 Business Update
With the global spread of the ongoing
COVID-19 pandemic in 2020, we have implemented business continuity plans designed to address and mitigate the impact of the COVID-19 pandemic on our employees and our
business, including our preclinical studies and clinical trials. Our operations are considered an essential business and we are continuing to operate during this period. We have taken measures to secure our research and development activities. While
we are experiencing limited financial impacts at this time, given the global economic slowdown, the overall disruption of global healthcare systems and the other risks and uncertainties associated with the pandemic, our business, financial condition
and results of operations could be materially adversely affected. We continue to closely monitor the COVID-19 pandemic as we evolve our business continuity plans, clinical development plans and response
strategy.
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In addition, while we have taken and are continuing to take steps to mitigate against
possible delays, our planned clinical trials may be affected by the COVID-19 pandemic, including (i) delays or difficulties in enrolling and retaining patients in our planned clinical trials, including
patients that may not be able or willing to comply with clinical trial protocols if quarantines impede patient movement or interrupt healthcare services; (ii) delays or difficulties in clinical site initiation, including difficulties in
recruiting and retaining clinical site investigators and clinical site staff; (iii) diversion or prioritization of healthcare resources away from the conduct of clinical trials and towards the COVID-19
pandemic, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of our clinical trials, and because, who, as healthcare providers, may have heightened exposure to COVID-19 and adversely impact our clinical trial operations; (iv) interruption of our future clinical supply chain or key clinical trial activities, such as clinical trial site monitoring, due to limitations on
travel imposed or recommended by federal, state/provincial or municipal governments, employers and others; and (v) limitations in outsourced third-party resources that would otherwise be focused on the conduct of our planned clinical trials,
including because of sickness of third-party personnel or their families, or the desire of third-party personnel to avoid contact with large groups of people.
Financial Operations Overview
Revenue
We have not generated any revenue since inception and do not expect to generate any revenue from the sale of products for several years, if at
all. If our development efforts for our current or future product candidates are successful and result in marketing approval or collaboration or license agreements with third parties, we may generate revenue in the future from a combination of
product sales or payments from collaboration or license agreements that we may enter into with third parties.
Operating Expenses
Research and Development Expense
The
nature of our business and primary focus of our activities generate a significant amount of research and development costs. Research and development expenses represent costs incurred by us for the following:
costs to develop our portfolio;
discovery efforts leading to development candidates;
clinical development costs for our programs; and
costs to develop our manufacturing technology and infrastructure.
The costs above comprise the following categories:
personnel-related expenses, including salaries, benefits and stock-based compensation expense;
expenses incurred under agreements with third parties, such as consultants, investigative sites and contract
research organizations, or CROs, that conduct our preclinical and clinical studies and in-licensing arrangements;
costs incurred to maintain compliance with regulatory requirements;
costs incurred with third-party contract manufacturing organizations, or CMOs, to acquire, develop and
manufacture materials for preclinical and clinical studies; and
depreciation, amortization and other direct and allocated expenses, including rent, insurance and other operating
costs, incurred as a result of our research and development activities.
We expense research and development costs as
incurred. We recognize external development costs based on an evaluation of the progress to completion of specific tasks using information provided to us by our vendors and our clinical investigative sites. Payments for these activities are based on
the terms of the individual agreements, which may differ from the pattern of costs incurred, and are reflected in our consolidated balance sheets as prepaid expenses or accrued research and development expenses.
Non-refundable advance payments for goods or services to be received in the future for use in research and development activities are deferred and capitalized, even when there is no alternative future use for
the research and development. The capitalized amounts are expensed as the related goods are delivered or the services are performed.
A
significant portion of our research and development costs have been external costs. We track direct external research and development expenses to specific programs upon commencement. Due to the number of ongoing programs and our ability to use
resources across several projects, indirect or shared operating costs incurred for our research and development programs, such as personnel, facility costs and certain consulting costs, are not recorded or maintained on a program-specific basis.
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Our major programs, PRAX-114, PRAX-944 and PRAX-562, are those for which we have initiated clinical activities. Our discovery-stage programs are those which are at an earlier point in the development
process. The following table reflects our research and development expenses, including direct program-specific expenses summarized by major program, discovery-stage program costs and indirect or shared operating costs recognized as research and
development expenses during each period presented (in thousands):
Three Months Ended
September 30,
Nine Months Ended
September 30,
2020
2019
2020
2019
PRAX-114
$
4,077
$
1,241
$
9,137
$
6,122
PRAX-944
1,707
862
3,284
3,641
PRAX-562
885
873
2,527
3,132
Discovery-stage programs
2,154
4,294
4,050
5,024
Personnel-related (including stock-based compensation)
3,098
1,405
7,443
3,946
Other indirect research and development expenses
865
671
2,263
1,993
Total research and development expenses
$
12,786
$
9,346
$
28,704
$
23,858
Research and development activities are central to our business model. Product candidates in later stages of
clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We expect that our research and development expenses
will continue to increase in the foreseeable future as we advance our product candidates through the development phase, and as we continue to discover and develop additional product candidates, build manufacturing capabilities and expand into
additional therapeutic areas.
At this time, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts
that will be necessary to complete the development of, and obtain regulatory approval for, any of our product candidates. We are also unable to predict when, if ever, material net cash inflows will commence from sales or licensing of our product
candidates. This is due to the numerous risks and uncertainties associated with drug development, including the uncertainty of:
our ability to add and retain key research and development personnel;
the timing and progress of preclinical and clinical development activities;
the number and scope of preclinical and clinical programs we decide to pursue;
our ability to successfully complete clinical trials with safety, tolerability and efficacy profiles that are
satisfactory to the U.S. Food and Drug Administration, or FDA, or any comparable foreign regulatory authority;
our ability to successfully develop, obtain regulatory approval for, and then successfully commercialize, our
product candidates;
our successful enrollment in and completion of clinical trials;
the costs associated with the development of any additional product candidates we identify in-house or acquire through collaborations;
our ability to discover, develop and utilize biomarkers to demonstrate target engagement, pathway engagement and
the impact on disease progression of our product candidates;
our ability to establish and maintain agreements with third-party manufacturers for clinical supply for our
clinical trials and commercial manufacturing, if our product candidates are approved;
the terms and timing of any collaboration, license or other arrangement, including the terms and timing of any
milestone payments thereunder;
our ability to obtain and maintain patent, trade secret and other intellectual property protection and regulatory
exclusivity for our product candidates if and when approved;
our receipt of marketing approvals from applicable regulatory authorities;
our ability to commercialize products, if and when approved, whether alone or in collaboration with others; and
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the continued acceptable safety profiles of the product candidates following approval.
A change in any of these variables with respect to the development of any of our product candidates would significantly change the costs,
timing and viability associated with the development of that product candidate. For example, if the FDA or another regulatory authority were to delay our planned start of clinical trials or require us to conduct clinical trials or other testing
beyond those that we currently expect, or if we experience significant delays in enrollment in any of our planned clinical trials, we could be required to expend significant additional financial resources and time to complete our clinical
development activities. We may never obtain regulatory approval for any of our product candidates. Drug commercialization will take several years and millions of dollars in development costs.
General and Administrative Expense
General and administrative expenses consist primarily of personnel-related costs, including salaries, benefits and stock-based compensation,
for personnel in our executive, finance, legal, business development and administrative functions. General and administrative expenses also include legal fees relating to corporate matters; professional fees for accounting, auditing, tax and
administrative consulting services; insurance costs; administrative travel expenses; and facility-related expenses, which include direct depreciation costs and allocated expenses for office rent and other operating costs. These costs relate to the
operation of the business, unrelated to the research and development function, or any individual program. Costs to secure and defend our intellectual property, or IP, are expensed as incurred and are classified as general and administrative
expenses.
We anticipate that our general and administrative expenses will increase in the future as we increase our headcount to support
the expected growth in our research and development activities and the potential commercialization of our product candidates. We also expect to incur increased expenses associated with being a public company, including increased costs of accounting,
audit, legal, regulatory and tax-related services associated with maintaining compliance with exchange listing and SEC requirements, director and officer insurance costs and investor and public relations
costs. We also expect to incur additional IP-related expenses as we file patent applications to protect innovations arising from our research and development activities.
Other Income
Interest Income
Interest income consists of interest earned on our cash and cash equivalents.
Income Taxes
Since our inception,
we have not recorded any U.S. federal or state income tax benefits for the net losses we have incurred in each year or for our earned research and development tax credits, due to our uncertainty of realizing a benefit from those items. Income taxes
are determined at the applicable tax rates adjusted for non-deductible expenses, research and development tax credits and other permanent differences. Our income tax provision may be significantly affected by
changes to our estimates. The income tax benefit recognized for the nine months ended September 30, 2020 related to income tax associated with our operations in Australia.
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Results of Operations
Comparison of the Three Months Ended September 30, 2020 and 2019
The following table summarizes our consolidated statements of operations for each period presented (in thousands):
Three Months Ended
September 30,
Change
2020
2019
Operating expenses:
Research and development
$
12,786
$
9,346
$
3,440
General and administrative
3,431
1,308
2,123
Total operating expenses
16,217
10,654
5,563
Loss from operations
(16,217
)
(10,654
)
(5,563
)
Other income:
Interest income
1
48
(47
)
Total other income
1
48
(47
)
Net loss
$
(16,216
)
$
(10,606
)
$
(5,610
)
Research and Development Expense
The following table summarizes our research and development expenses for each period presented, along with the changes in those items (in
thousands):
Three Months Ended
September 30,
Change
2020
2019
PRAX-114
$
4,077
$
1,241
$
2,836
PRAX-944
1,707
862
845
PRAX-562
885
873
12
Discovery-stage programs
2,154
4,294
(2,140
)
Personnel-related (including stock-based compensation)
3,098
1,405
1,693
Other indirect research and development expenses
865
671
194
Total research and development expenses
$
12,786
$
9,346
$
3,440
Research and development expenses increased approximately $3.4 million from $9.3 million for the
three months ended September 30, 2019 to $12.8 million for the three months ended September 30, 2020. The increase in research and development expenses was primarily attributable to the following:
$2.8 million increase in expense related to our PRAX-114 program,
driven by a $2.4 million increase in clinical-related spend and a $0.4 million increase in manufacturing spend both related to our ongoing Phase 2a clinical trial for this program;
$1.7 million increase in personnel-related costs due to increased headcount;
$0.8 million increase in expense related to our PRAX-944 program,
driven primarily by a $0.9 million increase in clinical-related spend for our ongoing Phase 2a clinical trial;
$0.2 million increase in other indirect research and development expenses, primarily driven by an increase
in facility, office, software and other overhead costs due to increased research and development headcount; and
$2.1 million offsetting decrease in expense related to our discovery-stage programs, primarily driven by a
$2.0 million decrease in research and development spend for discovery program assets acquired in the prior year.
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General and Administrative Expense
General and administrative expenses increased $2.1 million from $1.3 million for the three months ended September 30, 2019 to
$3.4 million for the three months ended September 30, 2020. The increase in general and administrative expenses was primarily attributable to the following:
$1.1 million increase in professional fees including legal and consulting services, driven by a
$0.5 million increase in accounting costs as we prepared for our IPO, a $0.4 million increase in legal fees, primarily related to intellectual property filings as we expand our research and development activities, and a $0.2 million
increase in corporate development-related work; and
$1.0 million increase in personnel-related costs driven by increased headcount.
Other Income
Other income for the three
months ended September 30, 2020 and 2019, comprised of interest income on our cash and cash equivalents, was not material.
Comparison of the
Nine Months Ended September 30, 2020 and 2019
The following table summarizes our consolidated statements of operations for
each period presented (in thousands):
Nine Months Ended
September 30,
Change
2020
2019
Operating expenses:
Research and development
$
28,704
$
23,858
$
4,846
General and administrative
7,552
4,437
3,115
Total operating expenses
36,256
28,295
7,961
Loss from operations
(36,256
)
(28,295
)
(7,961
)
Other income:
Interest income
134
171
(37
)
Total other income
134
171
(37
)
Loss before benefit from income taxes
(36,122
)
(28,124
)
(7,998
)
Benefit from income taxes
(8
)
(8
)
Net loss
$
(36,114
)
$
(28,124
)
$
(7,990
)
Research and Development Expense
The following table summarizes our research and development expenses for each period presented, along with the changes in those items (in
thousands):
Nine Months Ended
September 30,
Change
2020
2019
PRAX-114
$
9,137
$
6,122
$
3,015
PRAX-944
3,284
3,641
(357
)
PRAX-562
2,527
3,132
(605
)
Discovery-stage programs
4,050
5,024
(974
)
Personnel-related (including stock-based compensation)
7,443
3,946
3,497
Other indirect research and development expenses
2,263
1,993
270
Total research and development expenses
$
28,704
$
23,858
$
4,846
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Research and development expenses increased $4.8 million from $23.9 million for
the nine months ended September 30, 2019, to $28.7 million for the nine months ended September 30, 2020. The increase in research and development expenses was primarily attributable to the following:
$3.5 million increase in personnel-related costs due to increased headcount;
$3.0 million increase expense related to our PRAX-114 program,
driven primarily by a $3.6 million increase in clinical-related spend for our ongoing Phase 2a clinical trial for this program, partially offset by a $0.5 million decrease related to pre-clinical
expenses incurred during the nine months ended September 30, 2019;
$0.3 million increase in other indirect research and development expenses, primarily driven by an increase
in facility, office, software and other overhead costs due to increased research and development headcount;
$1.0 million offsetting decrease in discovery-stage program expense, driven by a $0.7 million decrease
in expense for discovery program assets acquired in the prior year and a $0.3 million decrease in spend for our other discovery-stage programs;
$0.6 million offsetting decrease in our PRAX-562 program, driven by
a $1.7 million decrease related to pre-clinical expenses incurred during the nine months ended September 30, 2019 to identify our clinical candidate, offset by a $0.7 million increase in
clinical-related spend and a $0.4 million manufacturing spend related to our ongoing Phase 1 clinical trial for this program; and
$0.4 million offsetting decrease in expense related to our PRAX-944
program, driven by a $1.1 million decrease for pre-clinical work performed during the nine months ended September 30, 2019 to prepare for our Phase 2a clinical trial and a $0.6 million decrease
related to a drug product manufacturing campaign that was executed during the nine months ended September 30, 2019, offset by a $1.3 million increase in clinical-related spend for our ongoing Phase 2 clinical trial for this program.
General and Administrative Expense
General and administrative expenses increased approximately $3.1 million from $4.4 million for the nine months ended
September 30, 2019 to $7.6 million for the nine months ended September 30, 2020. The increase in general and administrative expenses was primarily attributable to the following:
$1.6 million increase in professional fees including legal and consulting services, driven by a
$1.2 million increase in consulting costs, including $0.8 million of increased accounting costs as we prepared for the IPO and $0.3 million of increased corporate development spend to support commercial assessments of our
clinical-stage programs, and a $0.4 million increase in legal fees primarily related to intellectual property filings as we expand our research and development activities;
$1.4 million increase in personnel-related costs driven by increased headcount; and
$0.1 million increase in facilities, office and other general and administrative expenses to support the
increase in our operating activities.
Total Other Income
Total other income for the nine months ended September 30, 2020 and 2019 was $0.1 million and $0.2 million, respectively,
comprised of interest income on our cash and cash equivalents.
Liquidity and Capital Resources
Sources of Liquidity
Since our
inception, we have incurred significant losses in each period. We have not yet commercialized any of our product candidates, which are in various phases of preclinical and clinical development, and we do not expect to generate revenue from sales of
any products for several years, if at all. To date, we have financed our operations primarily with proceeds from sales of our redeemable convertible preferred stock, the issuance of convertible debt and the closing of our IPO.
Prior to our IPO, we raised an aggregate of $206.7 million in proceeds from the sale of our redeemable convertible preferred stock and
$4.0 million in proceeds from the issuance of convertible promissory notes. As of September 30, 2020, we had cash and cash equivalents of $114.8 million. On October 20, 2020, we completed our IPO for approximately
$199.9 million in net proceeds after deducting underwriting discounts and commissions and offering expenses payable by us.
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Historical Cash Flows
The following table provides information regarding our cash flows for each period presented (in thousands):
Nine Months Ended
September 30,
2020
2019
Net cash provided by (used in):
Operating activities
$
(32,395
)
$
(23,466
)
Investing activities
(103
)
Financing activities
102,352
9,939
Net increase (decrease) in cash, cash equivalents and restricted cash
$
69,957
$
(13,630
)
Operating Activities
Our cash flows from operating activities are greatly influenced by our use of cash for operating expenses and working capital requirements to
support the business. We have historically experienced negative cash flows from operating activities as we have invested in developing our portfolio, drug discovery efforts and related infrastructure. The cash used in operating activities resulted
primarily from our net losses adjusted for non-cash charges and changes in components of working capital, which are primarily the result of increased expenses and timing of vendor payments.
During the nine months ended September 30, 2020, net cash used in operating activities of $32.4 million was primarily due to our
$36.1 million net loss, partially offset by $1.9 million of non-cash charges and $1.8 million in changes in operating assets and liabilities.
During the nine months ended September 30, 2019, net cash used in operating activities of $23.5 million was primarily due to our
$28.1 million net loss, partially offset by $1.0 million of non-cash charges and $3.6 million in changes in operating assets and liabilities.
Investing Activities
There were no cash
flows from investing activities during the nine months ended September 30, 2020. During the nine months ended September 30, 2019, net cash used in investing activities related to the purchase of property and equipment.
Financing Activities
During the nine
months ended September 30, 2020, net cash provided by financing activities of $102.4 million consisted of net proceeds from the issuance of our Series C redeemable convertible preferred stock and Series
C-1 redeemable convertible preferred stock and exercise of stock options, offset by the cash paid for the repurchase of our Series C redeemable convertible preferred stock and cash paid for initial public
offering costs incurred.
During the nine months ended September 30, 2019, net cash provided by financing activities of
$9.9 million consisted of net proceeds from the issuance of our Series B-1 redeemable convertible preferred stock.
Plan of Operation and Future Funding Requirements
We expect our expenses to increase substantially in connection with our ongoing research and development activities, particularly as we advance
the preclinical activities and clinical trials of our product candidates. In addition, we expect to incur additional costs associated with operating as a public company. As a result, we expect to incur substantial operating losses and negative
operating cash flows for the foreseeable future. We anticipate that our expenses will increase substantially if and as we:
advance the clinical development of our PRAX-114, PRAX-944 and PRAX-562 product candidates;
advance the development of any additional product candidates;
conduct research and continue preclinical development of potential product candidates;
make strategic investments in manufacturing capabilities;
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maintain our current intellectual property portfolio and opportunistically acquire complementary intellectual
property;
seek to obtain regulatory approvals for our product candidates;
potentially establish a sales, marketing and distribution infrastructure and
scale-up manufacturing capabilities to commercialize any products for which we may obtain regulatory approval;
add clinical, scientific, operational, financial and management information systems and personnel, including
personnel to support our product development and potential future commercialization efforts and to support our transition to a public company; and
experience any delays or encounter any issues with any of the above, including but not limited to failed studies,
complex results, safety issues or other regulatory challenges.
We are unable to estimate the exact amount of our
working capital requirements, but based on our current operating plan, we believe that our existing cash and cash equivalents, combined with the cash proceeds from our IPO, will enable us to fund our operating expenses and capital expenditure
requirements into the fourth quarter of 2022. However, we have based this estimate on assumptions that may prove to be wrong and we could exhaust our capital resources sooner than we expect.
Because of the numerous risks and uncertainties associated with product development, and because the extent to which we may enter into
collaborations with third parties for the development of our product candidates is unknown, we may incorrectly estimate the timing and amounts of increased capital outlays and operating expenses associated with completing the research and
development of our product candidates. Our funding requirements and timing and amount of our operating expenditures will depend on many factors, including, but not limited to:
the scope, progress, results and costs of preclinical studies and clinical trials for our programs and product
candidates;
the number and characteristics of programs and technologies that we develop or may
in-license;
the costs and timing of future commercialization activities, including manufacturing, marketing, sales and
distribution, for any of our product candidates for which we receive marketing approval;
the costs necessary to obtain regulatory approvals, if any, for products in the United States and other
jurisdictions, and the costs of post-marketing studies that could be required by regulatory authorities in jurisdictions where approval is obtained;
the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our
intellectual property rights and defending any intellectual property-related claims;
the continuation of our existing licensing arrangements and entry into new collaborations and licensing
arrangements;
the costs we incur in maintaining business operations;
the costs associated with being a public company;
the revenue, if any, received from commercial sales of any product candidates for which we receive marketing
approval;
the effect of competing technological and market developments;
the impact of any business interruptions to our operations or to those of our manufacturers, suppliers or other
vendors resulting from the COVID-19 pandemic or similar public health crisis; and
the extent to which we acquire or invest in businesses, products and technologies, including entering into
licensing or collaboration arrangements for product candidates, although we currently have no commitments or agreements to complete any such acquisitions or investments in businesses.
Identifying potential product candidates and conducting preclinical testing and clinical trials is a time consuming, expensive and uncertain
process that takes years to complete, and we may never generate the necessary data or results required to obtain marketing approval and achieve product sales. In addition, our product candidates, if approved, may not achieve commercial success. Our
commercial revenues, if any, will be derived from sales of products that we do not expect to be commercially available for many years, if ever. Accordingly, we will need to obtain substantial additional funds to achieve our business objectives.
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Adequate additional funds may not be available to us on acceptable terms, or at all. We do
not currently have any committed external source of funds. Market volatility resulting from the COVID-19 pandemic or other factors could also adversely impact our ability to access capital as and when needed.
To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our existing stockholders will be diluted, and the terms of these securities may include liquidation or other
preferences that adversely affect the rights of holders of our common stock. Additional debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific
actions, such as incurring additional debt, making capital expenditures or declaring dividends and may require the issuance of warrants, which could potentially result in dilution to the holders of our common stock.
If we raise additional funds through collaborations, strategic alliances or licensing arrangements with third parties, we may have to
relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings
when needed, we may be required to delay, limit or terminate our product development programs or any future commercialization efforts or grant rights to develop and market product candidates to third parties that we would otherwise prefer to develop
and market ourselves.
Contractual Obligations
There have been no changes to our contractual obligations from those described under the heading Managements Discussion and
Analysis of Financial Condition and Results of Operations Contractual Obligations and Commitments in our final prospectus filed with the SEC pursuant to Rule 424(b)(4) on October 16, 2020.
Off-Balance Sheet Arrangements
We did not have during the periods presented, and we do not currently have, any off-balance sheet
arrangements, as defined in the rules and regulations of the SEC.
Critical Accounting Policies and Significant Judgments and Estimates
Our managements discussion and analysis of our financial condition and results of operations is based on our condensed consolidated
financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States, or GAAP. The preparation of these condensed consolidated financial statements requires us to make estimates and
assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, as well as the reported expenses incurred during the
reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets
and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
There have been no changes to our critical accounting policies from those described under the heading Managements Discussion and
Analysis of Financial Condition and Results of Operations Critical Accounting Policies and Significant Judgments and Estimates included in our final prospectus filed with the SEC pursuant to Rule 424(b)(4) on October 16, 2020.
JOBS Act and Emerging Growth Company and Smaller Reporting Company Status
In April 2012, the JOBS Act was enacted. As an emerging growth company, or EGC, under the JOBS Act, we may delay the adoption of certain
accounting standards until such time as those standards apply to private companies. Other exemptions and reduced reporting requirements under the JOBS Act for EGCs include presentation of only two years of audited financial statements in a
registration statement for an initial public offering, an exemption from the requirement to provide an auditors report on internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act of 2002, an
exemption from any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation and less extensive disclosure about our executive compensation arrangements. Additionally, the JOBS Act
provides that an EGC can take advantage of an extended transition period for complying with new or revised accounting standards. This allows an EGC to delay the adoption of certain accounting standards until those standards would otherwise apply to
private companies. We have elected to avail ourselves of the extended transition period and, therefore, while we are an EGC we will not be subject to new or revised accounting standards at the same time that they become applicable to other public
companies that are not EGCs, unless we choose to early adopt a new or revised accounting standard.
We will remain classified as an EGC
until the earlier of: (i) the last day of our first fiscal year in which we have total annual gross revenues of $1.07 billion or more, (ii) the last day of the fiscal year following the fifth anniversary of completion of our IPO,
(iii) the date on which we have issued more than $1.0 billion of non-convertible debt instruments during the previous three fiscal years or (iv) the date on which we are deemed a large
accelerated filer under the rules of the SEC.
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We are also a smaller reporting company as defined in the Securities Exchange
Act of 1934, as amended. We may continue to be a smaller reporting company even after we are no longer an emerging growth company. We may take advantage of certain of the scaled disclosures available to smaller reporting companies until the fiscal
year following the determination that our voting and non-voting common stock held by non-affiliates is more than $250 million measured on the last business day of
our second fiscal quarter, or our annual revenues are less than $100 million during the most recently completed fiscal year and our voting and non-voting common stock held by non-affiliates is more than $700 million measured on the last business day of our second fiscal quarter.
Recently Issued Accounting Pronouncements
We have reviewed all recently issued standards and have determined that, other than as disclosed in Note 2 to our condensed consolidated
financial statements appearing elsewhere in this Quarterly Report on Form 10-Q, such standards will not have a material impact on our condensed consolidated financial statements or do not otherwise apply to
our current operations.
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.