10-Q
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2023

OR

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from __________________to __________________

Commission File Number: 001-39409

 

ALLOVIR, INC.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware

 

83-1971007

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

1100 Winter Street, Waltham, MA

 

02451

(Address of principal executive offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code: (617) 433-2605

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange on which registered

Common Stock, par value $0.0001 per share

 

ALVR

 

The Nasdaq Global Select Market

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer

Accelerated filer

 

 

 

 

 

 

 

Non-accelerated filer

Smaller reporting company

 

 

 

 

 

 

 

 

 

 

 

Emerging growth company

 

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No

As of October 27, 2023, the registrant had 114,063,336 shares of common stock, $0.0001 par value per share, outstanding.

 

 

 

 

 


 

Table of Contents

 

Page

PART I.

FINANCIAL INFORMATION

4

Item 1.

Financial Statements (unaudited)

4

Condensed Consolidated Balance Sheets

4

Condensed Consolidated Statements of Operations and Comprehensive Loss

5

Condensed Consolidated Statements of Changes in Stockholders’ Equity

6

Condensed Consolidated Statements of Cash Flows

8

Notes to Condensed Consolidated Financial Statements

9

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

17

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

25

Item 4.

Controls and Procedures

25

 

 

 

PART II.

OTHER INFORMATION

27

Item 1.

Legal Proceedings

27

Item 1A.

Risk Factors

27

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

69

Item 3.

Defaults Upon Senior Securities

69

Item 4.

Mine Safety Disclosures

69

Item 5.

Other Information

69

Item 6.

Exhibits

70

 

 

 

Signatures

71

 

i


 

Summary of Material Risks Associated with Our Business

Our business is subject to numerous risks and uncertainties that you should be aware of before making an investment decision, including those highlighted in the section entitled “Risk Factors.” These risks include, but are not limited to, the following:

 

We are a late clinical-stage cell therapy company and we have incurred net losses since our inception. We anticipate that we will continue to incur significant losses for the foreseeable future and may never achieve or maintain profitability.

 

Our business is highly dependent on our lead product candidate, posoleucel (previously referred to as Viralym-M or ALVR105), and we must complete clinical testing before we can seek regulatory approval and begin commercialization of any of our product candidates.

 

We depend substantially on intellectual property licensed from third parties, including Baylor College of Medicine, or BCM, and termination of any of these licenses could result in the loss of significant rights, which would harm our business.

 

If we are unable to obtain and maintain sufficient intellectual property protection for our product candidates and manufacturing process, or if the scope of the intellectual property protection is not sufficiently broad, our ability to commercialize our product candidates successfully and to compete effectively may be adversely affected.

 

We will need substantial additional funding, and if we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our product discovery and development programs or commercialization efforts.

 

We have a limited operating history, which may make it difficult to evaluate the success of our business to date and to assess our future viability.

 

We are early in our development efforts and have only a small number of product candidates in clinical development. All of our other product candidates are still in preclinical development. If we or our collaborators are unable to successfully develop and commercialize product candidates or experience significant delays in doing so, our business may be materially harmed.

 

Clinical drug development involves a lengthy and expensive process with an uncertain outcome, and the inability to successfully and timely conduct clinical trials and obtain regulatory approval for our product candidates would substantially harm our business.

 

The results of preclinical studies or earlier clinical trials are not necessarily predictive of future results. Our existing product candidates in clinical trials, and any other product candidate we advance into clinical trials, may not have favorable results in later clinical trials or receive regulatory approval.

 

Our product candidates, the methods used to deliver them or their dosage levels may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label or result in significant negative consequences following any regulatory approval.

 

We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do.

 

We and our third-party partners are subject to a multitude of manufacturing risks, any of which could substantially increase our costs and limit supply of our product candidates.

 

We intend to develop an efficient and highly productive manufacturing supply chain for our allogeneic, off-the-shelf single- and multi-virus specific T cell therapies. Delays in process performance qualification to validate the drug product manufacturing process could delay regulatory approvals, our development plans and thereby limit our ability to generate revenues.

 

We are highly dependent on our key personnel and anticipate hiring new key personnel. If we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.

 

The trading price of our common stock may be volatile.
Our business could be adversely affected by the effects of health epidemics, like the COVID-19 pandemic, in regions where our contracted third parties, including contract research organizations, or CROs, and contract development and manufacturing organizations, or CMOs or CDMOs, have significant research, development or manufacturing facilities, concentrations of clinical trial sites or other business operations, causing disruption in supplies and services.

The summary risk factors described above should be read together with the text of the full risk factors below, in the section entitled “Risk Factors” and the other information set forth in this Quarterly Report on Form 10-Q, including our consolidated financial statements and the related notes, as well as in other documents that we file with the SEC. The risks summarized above or described in full below are not the only risks that we face. Additional risks and uncertainties not precisely known to us, or that we currently deem to be immaterial may also materially adversely affect our business, financial condition, results of operations and future growth prospects.

1


 

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q are forward-looking statements, including but not limited to, statements about:

the success, cost, timing and potential indications of our product development activities and clinical trials, including the ongoing and future clinical trials of posoleucel and ALVR106;
the timing of our planned Investigational New Drug, or IND, submissions to the U.S. Food and Drug Administration, or FDA, for our product candidates, including ALVR107;
the timing of the initiation, enrollment and completion of planned clinical trials;
our plans to research, develop and commercialize our product candidates, including posoleucel, ALVR106, and ALVR107;
the timing of the initiation, completion and outcomes of our preclinical studies;
the costs of development of any of our product candidates or clinical development programs and our ability to obtain funding for our operations, including funding necessary to complete the clinical trials of any of our product candidates;
our ability to successfully manufacture and distribute posoleucel, ALVR106 or any other future product or product candidate;
the potential benefits of and our ability to maintain our collaboration with our existing collaborators, including BCM, and establish or maintain future collaborations or strategic relationships or obtain additional funding;
the ability to maintain our existing license agreements, including Baylor College of Medicine, or BCM, and to license additional intellectual property relating to any future product candidates and to comply with our existing license agreements;
our ability to attract and retain collaborators with development, regulatory and commercialization expertise;
risks associated with a health epidemic like the COVID-19 pandemic, including the emergence of new COVID-19 variants, which may adversely impact our business and clinical trials;
the size of the markets for our VST product candidates, and our ability to serve those markets;
whether the results of our clinical trials will be sufficient to support domestic or foreign regulatory approvals for any of our product candidates;
our ability to successfully commercialize our product candidates, including posoleucel and ALVR106;
the rate and degree of market acceptance of our product candidates, including posoleucel and ALVR106;
our ability to obtain and maintain regulatory approval of our product candidates in any of the indications for which we plan to develop them, and any related restrictions, limitations or warnings in the label of any approved product we develop;
our ability to develop and maintain sales and marketing capabilities, whether alone or with potential future collaborators;
regulatory developments in the United States and foreign countries with respect to our product candidates or our competitors’ products and product candidates;
our reliance on third-party contract manufacturers and the performance of our third-party suppliers and manufacturers to manufacture and supply our product candidates for us;
the success of competing therapies that are or become available;
our ability to attract and retain key scientific or management personnel;
our expectation about the period of time over which our existing capital resources will be sufficient to fund our operating expenses and capital expenditures
our expectations regarding the time during which we will be an emerging growth company under the Jumpstart Our Business Startups Act of 2012, or the JOBS Act;
our financial performance;
the impact of laws and regulations;
developments and projections relating to our competitors or our industry;

2


 

the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for additional financing; and
our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates and our ability to operate our business without infringing on the intellectual property rights of others.

In some cases, you can identify forward-looking statements by the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “objective,” “ongoing,” “plan,” “predict,” “project,” “potential,” “should,” “will,” or “would,” or the negative of these terms, or other comparable terminology intended to identify statements about the future. These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements.

In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this report, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and investors are cautioned not to unduly rely upon these statements.

You should read the section titled “Risk Factors” set forth in Part II, Item 1A of this Quarterly Report on Form 10-Q, if any, for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties. As a result of these factors, we cannot assure you that the forward-looking statements in this Quarterly Report on Form 10-Q will prove to be accurate. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

You should read this Quarterly Report on Form 10-Q completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements.

3


 

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements (unaudited)

ALLOVIR, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

UNAUDITED

 

(in thousands, except share and per share amounts)

 

September 30,
2023

 

 

December 31,
2022

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

95,627

 

 

$

106,092

 

Short-term investments

 

 

117,691

 

 

 

127,703

 

Interest receivable

 

 

234

 

 

 

157

 

Prepaid expenses and other current assets

 

 

5,892

 

 

 

7,100

 

Prepaid expenses to related party

 

 

575

 

 

 

2,000

 

Total current assets

 

 

220,019

 

 

 

243,052

 

Restricted cash

 

 

852

 

 

 

852

 

Other assets

 

 

1,425

 

 

 

612

 

Property and equipment, net

 

 

673

 

 

 

930

 

Operating lease right-of-use assets

 

 

25,343

 

 

 

31,633

 

Total assets

 

$

248,312

 

 

$

277,079

 

Liabilities and stockholders’ equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

3,925

 

 

$

3,004

 

Accrued expenses

 

 

15,924

 

 

 

13,985

 

Income tax payable

 

 

 

 

 

128

 

Operating lease liability, current

 

 

12,976

 

 

 

7,165

 

Amount due to related party

 

 

241

 

 

 

56

 

Total current liabilities

 

 

33,066

 

 

 

24,338

 

Operating lease liability, long-term

 

 

19,912

 

 

 

28,222

 

Total liabilities

 

$

52,978

 

 

$

52,560

 

Stockholders’ equity:

 

 

 

 

 

 

Preferred stock, $0.0001 par value: 10,000,000 shares authorized at September 30, 2023 and December 31, 2022, respectively; 0 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively

 

 

 

 

 

 

Common stock, $0.0001 par value: 300,000,000 and 150,000,000 shares authorized at September 30, 2023 and December 31, 2022, respectively; 113,972,541 and 93,268,069 shares issued at September 30, 2023 and December 31, 2022, respectively; and 113,966,594 and 93,093,243 shares outstanding at September 30, 2023 and December 31, 2022, respectively

 

 

11

 

 

 

9

 

Additional paid-in capital

 

 

792,020

 

 

 

690,753

 

Accumulated other comprehensive loss

 

 

(200

)

 

 

(468

)

Accumulated deficit

 

 

(596,497

)

 

 

(465,775

)

Total stockholders’ equity

 

 

195,334

 

 

 

224,519

 

Total liabilities and stockholders’ equity

 

$

248,312

 

 

$

277,079

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

4


 

ALLOVIR, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

UNAUDITED

 

 

 

Three Months Ended
September 30,

 

 

Nine Months Ended
September 30,

 

(in thousands, except share and per share amounts)

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

34,156

 

 

$

30,004

 

 

$

99,698

 

 

$

90,450

 

General and administrative

 

 

12,805

 

 

 

12,946

 

 

 

37,797

 

 

 

40,318

 

Total operating expenses

 

 

46,961

 

 

 

42,950

 

 

 

137,495

 

 

 

130,768

 

Loss from operations

 

 

(46,961

)

 

 

(42,950

)

 

 

(137,495

)

 

 

(130,768

)

Total other income (loss), net:

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

1,522

 

 

 

668

 

 

 

4,362

 

 

 

978

 

Other income (loss), net

 

 

1,167

 

 

 

210

 

 

 

2,411

 

 

 

(634

)

Loss before income taxes

 

 

(44,272

)

 

 

(42,072

)

 

 

(130,722

)

 

 

(130,424

)

Income tax expense

 

 

 

 

 

 

 

 

 

 

 

150

 

Net loss

 

$

(44,272

)

 

$

(42,072

)

 

$

(130,722

)

 

$

(130,574

)

Net loss per share — basic and diluted

 

$

(0.39

)

 

$

(0.50

)

 

$

(1.30

)

 

$

(1.83

)

Weighted-average common shares outstanding — basic and diluted

 

 

113,894,188

 

 

 

84,948,837

 

 

 

100,683,322

 

 

 

71,213,219

 

Comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(44,272

)

 

$

(42,072

)

 

$

(130,722

)

 

$

(130,574

)

Other comprehensive income (loss), net of tax:

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain (loss) on available-for-sale securities

 

 

25

 

 

 

(119

)

 

 

268

 

 

 

(408

)

Total other comprehensive income (loss)

 

 

25

 

 

 

(119

)

 

 

268

 

 

 

(408

)

Comprehensive loss

 

$

(44,247

)

 

$

(42,191

)

 

$

(130,454

)

 

$

(130,982

)

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

5


 

ALLOVIR, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY

UNAUDITED

 

 

 

Common Stock

 

 

Additional
Paid-In

 

 

Accumulated
Other
Comprehensive

 

 

Accumulated

 

 

Total
Stockholders’

 

(in thousands, except share amounts)

 

Shares

 

 

Amount

 

 

Capital

 

 

Loss

 

 

Deficit

 

 

Equity

 

Balance at December 31, 2021

 

 

63,565,886

 

 

$

7

 

 

$

522,479

 

 

$

(155

)

 

$

(297,065

)

 

$

225,266

 

Stock-based compensation

 

 

 

 

 

 

 

 

10,467

 

 

 

 

 

 

 

 

 

10,467

 

Issuance of common stock, upon vesting of restricted stock

 

 

698,241

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized loss on available-for-sale securities

 

 

 

 

 

 

 

 

 

 

 

(195

)

 

 

 

 

 

(195

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(43,863

)

 

 

(43,863

)

Balance at March 31, 2022

 

 

64,264,127

 

 

$

7

 

 

$

532,946

 

 

$

(350

)

 

$

(340,928

)

 

$

191,675

 

Stock-based compensation

 

 

 

 

 

 

 

 

10,951

 

 

 

 

 

 

 

 

 

10,951

 

Issuance of common stock, upon vesting of restricted stock

 

 

450,619

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Purchase of common stock under the 2020 Employee Stock Purchase Plan

 

 

73,357

 

 

 

 

 

 

244

 

 

 

 

 

 

 

 

 

244

 

Unrealized loss on available-for-sale securities

 

 

 

 

 

 

 

 

 

 

 

(94

)

 

 

 

 

 

(94

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(44,639

)

 

 

(44,639

)

Balance at June 30, 2022

 

 

64,788,103

 

 

$

7

 

 

$

544,141

 

 

$

(444

)

 

$

(385,567

)

 

$

158,137

 

Stock-based compensation

 

 

 

 

 

 

 

 

10,855

 

 

 

 

 

 

 

 

 

10,855

 

Issuance of common stock, upon vesting of restricted stock

 

 

393,911

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock in registered direct offering, net of $0.2 million issuance costs

 

 

27,458,095

 

 

 

2

 

 

 

126,423

 

 

 

 

 

 

 

 

 

126,425

 

Unrealized loss on available-for-sale securities

 

 

 

 

 

 

 

 

 

 

 

(119

)

 

 

 

 

 

(119

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(42,072

)

 

 

(42,072

)

Balance at September 30, 2022

 

 

92,640,109

 

 

$

9

 

 

$

681,419

 

 

$

(563

)

 

$

(427,639

)

 

$

253,226

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

6


 

ALLOVIR, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY

UNAUDITED

 

 

 

Common Stock

 

 

Additional
Paid-In

 

 

Accumulated
Other
Comprehensive

 

 

Accumulated

 

 

Total
Stockholders’

 

(in thousands, except share amounts)

 

Shares

 

 

Amount

 

 

Capital

 

 

Loss

 

 

Deficit

 

 

Equity

 

Balance at December 31, 2022

 

 

93,093,243

 

 

$

9

 

 

$

690,753

 

 

$

(468

)

 

$

(465,775

)

 

$

224,519

 

Stock-based compensation

 

 

 

 

 

 

 

 

10,029

 

 

 

 

 

 

 

 

 

10,029

 

Issuance of common stock, upon vesting of restricted stock

 

 

334,747

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain on available-for-sale securities

 

 

 

 

 

 

 

 

 

 

 

167

 

 

 

 

 

 

167

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(41,183

)

 

 

(41,183

)

Balance at March 31, 2023

 

 

93,427,990

 

 

$

9

 

 

$

700,782

 

 

$

(301

)

 

$

(506,958

)

 

$

193,532

 

Stock-based compensation

 

 

 

 

 

 

 

 

10,288

 

 

 

 

 

 

 

 

 

10,288

 

Issuance of common stock, upon vesting of restricted stock

 

 

179,092

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Purchase of common stock under the 2020 Employee Stock Purchase Plan

 

 

108,936

 

 

 

 

 

 

315

 

 

 

 

 

 

 

 

 

315

 

Issuance of common stock in public offering, net of underwriting discounts, commissions and offering costs

 

 

20,000,000

 

 

 

2

 

 

 

70,167

 

 

 

 

 

 

 

 

 

70,169

 

Unrealized gain on available-for-sale securities

 

 

 

 

 

 

 

 

 

 

 

76

 

 

 

 

 

 

76

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(45,267

)

 

 

(45,267

)

Balance at June 30, 2023

 

 

113,716,018

 

 

$

11

 

 

$

781,552

 

 

$

(225

)

 

$

(552,225

)

 

$

229,113

 

Stock-based compensation

 

 

 

 

 

 

 

 

10,468

 

 

 

 

 

 

 

 

 

10,468

 

Issuance of common stock, upon vesting of restricted stock

 

 

250,576

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain on available-for-sale securities

 

 

 

 

 

 

 

 

 

 

 

25

 

 

 

 

 

 

25

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(44,272

)

 

 

(44,272

)

Balance at September 30, 2023

 

 

113,966,594

 

 

$

11

 

 

$

792,020

 

 

$

(200

)

 

$

(596,497

)

 

$

195,334

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

7


 

ALLOVIR, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

UNAUDITED

 

 

 

Nine Months Ended
September 30,

 

(in thousands)

 

2023

 

 

2022

 

Cash flows from operating activities

 

 

 

 

 

 

Net loss

 

$

(130,722

)

 

$

(130,574

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

Depreciation and amortization

 

 

257

 

 

 

637

 

Non-cash lease expense

 

 

3,790

 

 

 

834

 

Accretion of short-term investment discounts

 

 

(2,486

)

 

 

(206

)

Stock-based compensation expense

 

 

30,785

 

 

 

32,273

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

Interest receivable

 

 

(77

)

 

 

(211

)

Prepaid expenses and other current assets and prepaid expenses to related party

 

 

2,633

 

 

 

(1,862

)

Other assets

 

 

(813

)

 

 

367

 

Income tax payable

 

 

(128

)

 

 

(853

)

Accounts payable, accrued expenses and amount due to related party

 

 

3,045

 

 

 

(10,886

)

Net cash used in operating activities

 

 

(93,716

)

 

 

(110,481

)

Cash flows from investing activities

 

 

 

 

 

 

Purchase of short-term investments

 

 

(116,046

)

 

 

(191,340

)

Maturities of short-term investments

 

 

128,813

 

 

 

97,325

 

Net cash provided by (used in) investing activities

 

 

12,767

 

 

 

(94,015

)

Cash flows from financing activities

 

 

 

 

 

 

Proceeds from issuance of common stock in public offering, net of underwriting discounts, commissions and offering costs

 

 

70,169

 

 

 

 

Proceeds from issuance of common stock in registered direct offering, net of issuance costs

 

 

 

 

 

126,425

 

Proceeds from issuance of stock under the 2020 Employee Stock Purchase Plan

 

 

315

 

 

 

244

 

Net cash provided by financing activities

 

 

70,484

 

 

 

126,669

 

Net decrease in cash, cash equivalents, and restricted cash

 

 

(10,465

)

 

 

(77,827

)

Cash, cash equivalents, and restricted cash at beginning of period

 

 

106,944

 

 

 

202,513

 

Cash, cash equivalents, and restricted cash at end of period

 

$

96,479

 

 

$

124,686

 

Non-cash investing and financing activities

 

 

 

 

 

 

Unrealized gain (loss) on available-for-sale securities

 

$

268

 

 

$

(408

)

Deferred offering costs included in accounts payable and accrued expenses

 

$

46

 

 

$

 

Reduction of right-of-use asset and operating lease liability due to modification and remeasurement

 

$

 

 

$

(5,506

)

Purchase of property and equipment included in accounts payable and accrued expenses

 

$

 

 

$

32

 

Supplemental disclosure of cash flows

 

 

 

 

 

 

Income taxes paid, net of refunds

 

$

351

 

 

$

1,003

 

 

 

 

 

 

 

 

Nine Months Ended
September 30,

 

 

2023

 

 

2022

 

Cash and cash equivalents

 

$

95,627

 

 

$