10-Q
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

FORM 10-Q

 

(Mark One)

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

For the quarterly period ended June 30, 2021

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.)

139 Main Street, Suite 500

Cambridge, MA

 

02142

(Address of principal executive offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code: (617433-2605

 

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 July 30, 2021, the registrant had 65,117,971 shares of common stock, $0.0001 par value per share, outstanding.

 

 

 

 

i


Table of Contents

 

Page

PART I.

FINANCIAL INFORMATION

 

Item 1.

Financial Statements (unaudited)

4

Condensed Consolidated Balance Sheets

4

Condensed Consolidated Statements of Operations and Comprehensive Loss

5

Condensed Consolidated Statements of Convertible Preferred Stock and Changes in Stockholders’ Equity (Deficit)

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

21

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

30

Item 4.

Controls and Procedures

31

 

 

 

PART II.

OTHER INFORMATION

 

Item 1.

Legal Proceedings

32

Item 1A.

Risk Factors

32

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

77

Item 3.

Defaults Upon Senior Securities

77

Item 4.

Mine Safety Disclosures

77

Item 5.

Other Information

77

Item 6.

Exhibits

78

 

 

 

Signatures

79

 

 

 

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:

Our business could be adversely affected by the effects of health epidemics, including the recent COVID-19 pandemic, in regions where third parties for which we rely, as in CROs or CMOs, have significant research, development or manufacturing facilities, concentrations of clinical trial sites or other business operations, causing disruption in supplies and services.

 

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) 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-VST-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.

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, ALVR106 and ALVR109;

• the timing of our planned Investigational New Drug (IND) submissions to the FDA for our product candidates, including ALVR109, ALVR107 and ALVR108;

• 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, ALVR109, ALVR107 and ALVR108;

• 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 and ALVR106 or any other future product or product candidate, including under the Development and Manufacturing Services Agreement with ElevateBio BaseCamp, Inc.;

• 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 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 the COVID-19 pandemic, 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, ALVR106 and ALVR109;

• the rate and degree of market acceptance of our product candidates, including posoleucel, ALVR106 and ALVR109;

• 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 JOBS Act;

• our financial performance;

2


• the impact of laws and regulations;

• developments and projections relating to our competitors or our industry;

• 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)

 

June 30,
2021

 

 

December 31,
2020

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

225,447

 

 

$

122,661

 

Short-term investments

 

 

87,890

 

 

 

233,663

 

Accrued interest

 

 

409

 

 

 

450

 

Prepaid expenses and other current assets

 

 

2,299

 

 

 

4,543

 

Total current assets

 

 

316,045

 

 

 

361,317

 

Other assets

 

 

692

 

 

 

 

Property and equipment, net

 

 

1,215

 

 

 

812

 

Operating lease right-of-use assets

 

 

9,559

 

 

 

8,692

 

Total assets

 

$

327,511

 

 

$

370,821

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

4,202

 

 

$

963

 

Accrued expenses

 

 

9,975

 

 

 

7,530

 

Operating lease liability, current

 

 

4,830

 

 

 

3,229

 

Amount due to related party

 

 

1,701

 

 

 

572

 

Total current liabilities

 

 

20,708

 

 

 

12,294

 

Operating lease liability, long term

 

 

4,334

 

 

 

5,463

 

Total liabilities

 

 

25,042

 

 

 

17,757

 

Stockholders’ equity:

 

 

 

 

 

 

Preferred stock, $0.0001 par value: 10,000,000 shares authorized at June 30, 2021 and December 31, 2020, respectively; 0 shares issued and outstanding at June 30, 2021 and December 31, 2020, respectively

 

 

 

 

 

 

Common stock, $0.0001 par value: 150,000,000 shares authorized at June 30, 2021 and December 31, 2020, respectively; 65,106,873 shares issued at June 30, 2021 and December 31, 2020, respectively; and 62,792,043 and 61,931,255 shares outstanding at June 30, 2021 and December 31, 2020, respectively

 

 

7

 

 

 

7

 

Additional paid-in capital

 

 

496,101

 

 

 

478,272

 

Accumulated other comprehensive loss

 

 

(25

)

 

 

(112

)

Accumulated deficit

 

 

(193,614

)

 

 

(125,103

)

Total stockholders’ equity

 

 

302,469

 

 

 

353,064

 

Total liabilities and stockholders’ equity

 

$

327,511

 

 

$

370,821

 

 

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
June 30,

 

 

Six Months Ended
June 30,

 

(in thousands, except share and per share amounts)

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

25,677

 

 

 

8,885

 

 

 

46,070

 

 

 

15,724

 

General and administrative

 

 

11,978

 

 

 

3,268

 

 

 

22,448

 

 

 

6,269

 

Total operating expenses

 

 

37,655

 

 

 

12,153

 

 

 

68,518

 

 

 

21,993

 

Loss from operations

 

 

(37,655

)

 

 

(12,153

)

 

 

(68,518

)

 

 

(21,993

)

Total other income (loss), net:

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

475

 

 

 

166

 

 

 

980

 

 

 

623

 

Other (loss) income, net

 

 

(408

)

 

 

355

 

 

 

(973

)

 

 

399

 

Net loss

 

$

(37,588

)

 

$

(11,632

)

 

$

(68,511

)

 

$

(20,971

)

Net loss per share — basic and diluted

 

$

(0.60

)

 

$

(4.43

)

 

$

(1.10

)

 

$

(8.66

)

Weighted-average common shares outstanding — basic and diluted

 

 

62,344,718

 

 

 

2,625,648

 

 

 

62,399,034

 

 

 

2,420,797

 

Comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(37,588

)

 

$

(11,632

)

 

$

(68,511

)

 

$

(20,971

)

Other comprehensive (loss) income, net of tax:

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

(16

)

 

 

(134

)

 

 

26

 

 

 

42

 

Foreign currency translation adjustment

 

 

(22

)

 

 

 

 

 

61

 

 

 

 

Total other comprehensive (loss) income

 

 

(38

)

 

 

(134

)

 

 

87

 

 

 

42

 

Comprehensive loss

 

$

(37,626

)

 

$

(11,766

)

 

$

(68,424

)

 

$

(20,929

)

 

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

5


ALLOVIR, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)

UNAUDITED

 

 

Series B
Preferred Stock

 

 

Series A
Preferred Stock

 

 

 

Common Stock

 

 

Additional
Paid-In

 

 

Accumulated
Other
Comprehensive

 

 

Accumulated

 

 

Total
Stockholders’

 

(in thousands, except share amounts)

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Income

 

 

Deficit

 

 

Deficit

 

Balance at December 31, 2019

 

14,877,697

 

 

$

120,923

 

 

 

44,520,653

 

 

$

52,204

 

 

 

 

2,099,740

 

 

$

 

 

$

3,748

 

 

$

68

 

 

$

(55,319

)

 

$

(51,503

)

Issuance of common stock, upon vesting of restricted stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

292,644

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain on available-for-sale securities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

176

 

 

 

 

 

 

176

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

646

 

 

 

 

 

 

 

 

 

646

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(9,339

)

 

 

(9,339

)

Balance at March 31, 2020

 

14,877,697

 

 

$

120,923

 

 

 

44,520,653

 

 

$

52,204

 

 

 

 

2,392,384

 

 

$

 

 

$

4,394

 

 

$

244

 

 

$

(64,658

)

 

$

(60,020

)

Issuance of common stock, upon vesting of restricted stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

409,475

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized loss available-for-sale securities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(134

)

 

 

 

 

 

(134

)

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

492

 

 

 

 

 

 

 

 

 

492

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(11,632

)

 

 

(11,632

)

Balance at June 30, 2020

 

14,877,697

 

 

$

120,923

 

 

 

44,520,653

 

 

$

52,204

 

 

 

 

2,801,859

 

 

$

 

 

$

4,886

 

 

$

110

 

 

$

(76,290

)

 

$

(71,294

)

 

6


ALLOVIR, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)

UNAUDITED

 

 

 

Common Stock

 

 

Additional
Paid-In

 

 

Accumulated
Other
Comprehensive

 

 

Accumulated

 

 

Total
Stockholders’

 

(in thousands, except share amounts)

 

Shares

 

 

Amount

 

 

Capital

 

 

Income (Loss)

 

 

Deficit

 

 

Equity

 

Balance at December 31, 2020

 

 

61,931,255

 

 

$

7

 

 

$

478,272

 

 

$

(112

)

 

$

(125,103

)

 

$

353,064

 

Stock-based compensation

 

 

 

 

 

 

 

 

8,103

 

 

 

 

 

 

 

 

 

8,103

 

Issuance of common stock, upon vesting of restricted stock

 

 

519,839

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain on available-for-sale securities

 

 

 

 

 

 

 

 

 

 

 

42

 

 

 

 

 

 

42

 

Foreign currency translation adjustment

 

 

 

 

 

 

 

 

 

 

 

83

 

 

 

 

 

 

83

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(30,923

)

 

 

(30,923

)

Balance at March 31, 2021

 

 

62,451,094

 

 

$

7

 

 

$

486,375

 

 

$

13

 

 

$

(156,026

)

 

$

330,369

 

Stock-based compensation

 

 

 

 

 

 

 

 

9,726

 

 

 

 

 

 

 

 

 

9,726

 

Issuance of common stock, upon vesting of restricted stock

 

 

340,949

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain on available-for-sale securities

 

 

 

 

 

 

 

 

 

 

 

(16

)

 

 

 

 

 

(16

)

Foreign currency translation adjustment

 

 

 

 

 

 

 

 

 

 

 

(22

)

 

 

 

 

 

(22

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(37,588

)

 

 

(37,588

)

Balance at June 30, 2021

 

 

62,792,043

 

 

$

7

 

 

$

496,101

 

 

$

(25

)

 

$

(193,614

)

 

$

302,469

 

 

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

 

7


 

ALLOVIR, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

UNAUDITED

 

 

 

Six Months Ended
June 30,

 

(in thousands)

 

2021

 

 

2020

 

Cash flows from operating activities

 

 

 

 

 

 

Net loss

 

$

(68,511

)

 

$

(20,971

)

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

 

 

 

 

 

 

Depreciation and amortization

 

 

51

 

 

 

37

 

Non-cash lease expense

 

 

210

 

 

 

 

Amortization and accretion of discounts on short-term investments

 

 

897

 

 

 

7

 

Stock compensation expense

 

 

17,829

 

 

 

1,138

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

Unbilled grant receivables

 

 

 

 

 

(56

)

Accrued interest

 

 

41

 

 

 

204

 

Prepaid expenses and other current assets

 

 

1,638

 

 

 

(1,749

)

Other assets

 

 

(692

)

 

 

 

Accounts payable, accrued expenses and amount due to related party

 

 

6,723

 

 

 

(271

)

Net cash used in operating activities

 

 

(41,814

)

 

 

(21,661

)

Cash flows from investing activities

 

 

 

 

 

 

Purchase of property and equipment

 

 

(363

)

 

 

 

Purchase of short-term investments

 

 

(30,098

)

 

 

(26,156

)

Maturities of short-term investments

 

 

175,000

 

 

 

65,000

 

Net cash provided by investing activities

 

 

144,539

 

 

 

38,844

 

Cash flows from financing activities

 

 

 

 

 

 

Net cash provided by financing activities

 

 

 

 

 

 

Effect of exchange rate changes on cash and cash equivalents

 

 

61

 

 

 

 

Net increase in cash and cash equivalents

 

 

102,786

 

 

 

17,183

 

Cash and cash equivalents at beginning of period

 

 

122,661

 

 

 

61,084

 

Cash and cash equivalents at end of period

 

$

225,447

 

 

$

78,627

 

Non-cash investing and financing activities

 

 

 

 

 

 

Unrealized gain on available-for-sale securities

 

$

26

 

 

$

42

 

Right-of-use assets obtained in exchange for operating lease liability

 

$

3,089

 

 

$

 

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

 

$

91

 

 

$

 

 

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

8


 

ALLOVIR, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

UNAUDITED

1. Nature of the Business

AlloVir, Inc. (“AlloVir” or “the Company”, formerly known as ViraCyte, Inc.) is a leading late clinical-stage cell therapy company developing highly innovative allogeneic T-cell therapies to treat and prevent devastating viral diseases. The Company’s innovative and proprietary virus-specific T-cell, or VST, therapy platform allows AlloVir to generate off-the-shelf VSTs designed to restore immunity in patients with T-cell deficiencies who are at risk from the life-threatening consequences of viral diseases. There is an urgent medical need for therapies to treat a large number of patients suffering from viral diseases who currently have limited or no treatment options. To date, the Company has generated five innovative, allogeneic, off-the-shelf VST therapy candidates targeting 12 different devastating viruses. The most advanced is posoleucel (previously referred to as Viralym-M), for which the Company has an ongoing pivotal trial for the treatment of virus-associated hemorrhagic cystitis and ongoing proof-of-concept, or POC, clinical trials for multi-virus prevention in HSCT and BKV in kidney transplant.

The Company’s lead product candidate, posoleucel, is a multi-VST-cell therapy that targets six viruses: BK virus, JC virus, cytomegalovirus, adenovirus, Epstein-Barr virus and human herpesvirus 6. To fully explore the clinical benefit of posoleucel, the Company plans to initiate an additional two Phase 3 pivotal and one Phase 2 proof-of-concept trials by the end of 2021 for the treatment and prevention of life-threatening viral diseases in pediatric and/or adult patients, each representing a potential meaningful commercial opportunity. In addition, ALVR106 is the Company’s second multi-virus-targeted off-the-shelf VST product candidate targeting devastating respiratory diseases caused by respiratory syncytial virus, or RSV, influenza, parainfluenza virus, or PIV, and human metapneumovirus, or hMPV. An Investigational New Drug, or IND, application with the FDA for ALVR106 was cleared in the fourth quarter of 2020 and the Company plans to initiate a Phase 1/2 clinical study in autologous and allogeneic HSCT patients with respiratory viral diseases in the second half of 2021. Pursuant to the sponsored research agreement with Baylor College of Medicine (“BCM”), BCM initiated a proof-of-concept trial for ALVR109, an allogeneic, off-the-shelf VST therapy designed to target SARS-CoV-2, the virus that causes the severe and life-threatening viral disease, COVID-19. ALVR109 is being developed to arrest the progression of COVID-19 by eradicating SARS-CoV-2 virus-infected cells. BCM initiated the POC clinical trial in the fourth quarter of 2020 and the trial is ongoing. With efficacy of available vaccine and therapies to prevent serious disease, we do not see a role for our COVID-19 therapy in a broad population. However, depending on the evolution of the SARS-CoV-2 virus, there may be a future role to treat immunocompromised patients who aren’t adequately served by available vaccines and therapies. We’re monitoring the evolution of the SARS-CoV-2 virus and the COVID-19 pandemic to guide the next steps for this program. Lastly, the Company is advancing ALVR107 designed to target hepatitis B, or HBV, infected cells and treat chronic HBV infections and ALVR108 to treat human herpesvirus-8, or HHV-8, associated diseases including Kaposi Sarcoma, or KS, primary effusion lymphoma, or PEL, and multicentric Castleman’s disease, or MCD. The Company plans to complete pre-clinical IND enabling studies for ALVR107 and ALVR108 in the second half of 2021.

The Company was formed on August 16, 2013 as a Delaware limited liability company (“LLC”) under the name AdCyte LLC and on July 29, 2014 the Company changed its name to ViraCyte LLC. On September 17, 2018, the Company converted from a Delaware LLC to a Delaware corporation (“LLC Conversion”) and changed its name to ViraCyte, Inc. On May 22, 2019, the Company changed its name to AlloVir, Inc. The Company has principal offices in Houston, Texas and Cambridge, Massachusetts.

On August 8, 2019, AlloVir formed AlloVir International Designated Activity Company (“AlloVir International”), a wholly-owned subsidiary established in Ireland.

On October 9, 2019, AlloVir Securities Corporation was incorporated as a Massachusetts Security Corporation, a wholly-owned subsidiary of AlloVir.

On November 10, 2019, AlloVir International formed AlloVir Italia S.R.L. (“AlloVir Italia”), a wholly-owned subsidiary in Italy.

On August 3, 2020, the Company completed an initial public offering (“IPO”) in which the Company issued and sold 18,687,500 shares of its common stock, at a public offering price of $17.00 per share, resulting in gross proceeds of $317.7 million. The Company received $292.0 million in net proceeds after deducting underwriting discounts and commissions and offering costs.

Upon the closing of the IPO, all of the then-outstanding shares of convertible preferred stock automatically converted into 39,859,139 shares of common stock at the applicable conversion ratio then in effect. Subsequent to the closing of the IPO, there were no shares of convertible preferred stock outstanding.

9


 

ElevateBio, LLC

On September 17, 2018, the Company executed a Series A2 Preferred Stock Purchase Agreement (“Series A2 Agreement”) with ElevateBio, LLC, a Delaware LLC (“ElevateBio”) concurrent with the LLC Conversion. ElevateBio was formed on November 29, 2017 and is headquartered in Cambridge, Massachusetts with a focus on the development of a portfolio of novel cell therapy programs acquired through business development activities with biotechnology companies. ElevateBio is structured as a holding company, comprised of asset-specific subsidiaries focused on the development of pipeline assets, as well as a manufacturing subsidiary with the expertise to provide drug development and manufacturing services. As a result of the purchase of the Company’s Series A2 Preferred Stock, ElevateBio acquired an ownership interest in the Company. The Chief Executive Officer, Chief Financial Officer, and other executives of ElevateBio have previously or currently serve in similar management roles with AlloVir. In May 2021, Diana M. Brainard M.D., succeeded David Hallal, ElevateBio's Chief Executive Officer, as the Company’s Chief Executive Officer and principal executive officer.

Going Concern

In accordance with Accounting Standards Update (“ASU”) 2014-15, Disclosure of Uncertainties about an Entity’s 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 Company’s ability to continue as a going concern within one year after the date the condensed consolidated financial statements are issued.

The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations and the ability to secure additional capital to fund operations. Product candidates 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 and reporting capabilities. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales.

The accompanying condensed consolidated financial statements have been prepared on the basis of continuity of operations, realization of assets and the satisfaction of liabilities and commitments in the ordinary course of business. Through June 30, 2021, the Company has funded its operations primarily with proceeds received from the sale of common stock, research grants, and from the sale of preferred stock. The Company has incurred recurring losses since its inception, including net losses attributable to common stockholders of $37.6 million and $11.6 million for the three months ended June 30, 2021 and 2020, respectively, and $68.5 million and $21.0 million for the six months ended June 30, 2021 and 2020, respectively. In addition, at June 30, 2021, the Company had an accumulated deficit of $193.6 million. The Company expects to continue to generate operating losses for the foreseeable future.

The Company believes that its $225.4 million of cash and cash equivalents and $87.9 million of short-term investments held at June 30, 2021, are sufficient to fund planned operations for at least twelve months from the date that these condensed consolidated financial statements are available to be issued.

COVID-19 Considerations

The development of product candidates could be disrupted and materially adversely affected in the future by a pandemic, epidemic or outbreak of an infectious disease, such as the recent COVID-19 pandemic. The spread of COVID-19 has impacted the global economy and has impacted the Company’s operations, including the interruption of preclinical and clinical trial activities and potential interruption to the Company’s supply chain. For example, the COVID-19 pandemic has delayed clinical trials. If the disruption due to the COVID-19 pandemic continues, planned pivotal clinical trials also could be delayed due to government orders and site policies on account of the pandemic, and some patients may be unwilling or unable to travel to study sites, enroll in trials or be unable to comply with clinical trial protocols if quarantines impede patient movement or interrupt healthcare services, which would delay the Company’s ability to conduct preclinical studies and clinical trials or release clinical trial results and could delay the Company’s ability to obtain regulatory approval and commercialize product candidates. Furthermore, COVID-19 could affect the Company’s employees or the employees of research sites and service providers on whom the Company relies on as well as those of companies with which the Company does business, including suppliers and contract manufacturing organizations or CMOs, thereby disrupting business operations. Quarantines and travel restrictions imposed by governments in the jurisdictions in which the Company and the companies with which it does business operate could materially impact the ability of employees to access preclinical and clinical sites, laboratories, manufacturing sites and offices. For the health and safety of our employees, the Company has implemented work-at-home policies and we have generally restricted on site staff to only those employees who are fully vaccinated or essential to the development and research of product candidates; accordingly, the Company may experience limitations in employee resources. The outbreak and any other preventative or protective actions that the Company, its suppliers or other third parties with which it has business relationships, or governments may take in respect of the COVID-19 pandemic, could disrupt, delay or otherwise adversely impact the business.

10


 

The Company is still assessing business plans and the impact the COVID-19 pandemic may have on its ability to advance the testing, development and manufacturing of drug candidates, including as a result of adverse impacts on the research sites, service providers, vendors, or suppliers on whom the Company relies on, or to raise financing to support the development of our drug candidates. No assurances can be given that this analysis will enable the Company to avoid part or all of any impact from the spread of COVID-19 or its consequences, including downturns in business sentiment generally or this sector in particular. The Company cannot presently predict the scope and severity of any potential business shutdowns or disruptions, but if the Company or any of the third parties on whom it relies on or with whom it conducts business, were to experience shutdowns or other business disruptions, the Company’s ability to conduct business in the manner and on the timelines presently planned could be materially and adversely impacted.

2. Summary of Significant Accounting Policies

The Company’s significant accounting policies are disclosed in the audited consolidated financial statements for the year ended December 31, 2020 (“annual financial statements”), which are included in the Company’s Annual Report on Form 10-K that was filed with the SEC on February 12, 2021. Since the date of those financial statements, there have been no changes to the Company’s significant accounting policies, except as noted below.

Interim Financial Information

The accompanying condensed consolidated balance sheet at June 30, 2021, and the condensed consolidated statements of operations and comprehensive loss, statements of convertible preferred stock and changes in stockholders’ equity (deficit) for the three and six months ended June 30, 2021 and 2020 and condensed consolidated statements of cash flows for the six months ended June 30, 2021 and 2020 are unaudited. The condensed consolidated interim financial statements have been prepared on the same basis as the audited annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments necessary for the fair presentation of the Company’s financial position at June 30, 2021 and the results of its operations for the three and six months ended June 30, 2021 and 2020 and its cash flows for the six months ended June 30, 2021 and 2020. The financial data and other information disclosed in these notes related to the three and six months ended June 30, 2021 and 2020 are also unaudited. The results for the three and six months ended June 30, 2021 are not necessarily indicative of results to be expected for the year ending December 31, 2021 or for any other subsequent interim period.

Cloud Computing Arrangements

The Company capitalizes certain implementation costs for internal-use software incurred in a cloud computing agreement that is a service contract. Eligible costs associated with cloud computing arrangements, such as the implementation costs incurred to develop of obtain software business applications used in the normal course of business, are capitalized in accordance with ASC 350. Capitalization ceases at the point the software is substantially complete and ready for its intended use, and after all substantial testing is completed. Amortization is recorded on a straight-line basis over the expected useful life of three years of the internal-use software cost in the same line item in the statement of operations and comprehensive loss as the expense for fees for the associated cloud computing arrangement. No amortization expense associated with the Company's cloud computing arrangements has been recognized during the three and six months ended June 30, 2021.

Recent Accounting Pronouncements

From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”), or other standard setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, the impact of recently issued standards that are not yet effective will not have a material impact on the Company’s consolidated financial statements upon adoption. Under the Jumpstart Our Business Startups Act of 2012, as amended (the “JOBS Act”), the Company meets the definition of an emerging growth company and has elected the extended transition period for complying with certain new or revised accounting standards pursuant to Section 107(b) of the JOBS Act.

Since December 31, 2020, there have been no new accounting pronouncements adopted by the Company or issued by FASB that are applicable to the Company, except as noted below.

Recently Adopted Accounting Pronouncements

In December 2019, the FASB issued ASU 2019-12 – Income Taxes (Topic 740) (“ASU 2019-12”), which removes certain exceptions from the guidance and simplifies the accounting for income taxes in certain areas. The Company adopted ASU 2019-12 on January 1, 2021. There was no material impact to the Company’s consolidated financial statements as a result of adopting this new standard.

11


 

Recently Issued Accounting Pronouncements Not Yet Adopted

In June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). ASU 2016-13 significantly changes the impairment model for most financial assets and certain other instruments. ASU 2016-13 will require immediate recognition of estimated credit losses expected to occur over the remaining life of many financial assets, which will generally result in earlier recognition of allowances for credit losses on loans and other financial instruments. ASU 2016-13 is effective for the Company’s fiscal year beginning after December 15, 2022 and subsequent interim periods. The adoption of this standard is not expected to have a material impact on the Company’s consolidated financial statements and related disclosures.  

3. Short-Term Investments

The following tables summarize the amortized cost and estimated fair value of the Company’s marketable securities, which are considered to be available-for-sale investments and were included in short-term investments on the condensed consolidated balance sheets:

 

 

 

June 30, 2021

 

(in thousands)

 

Amortized
Cost

 

 

Unrealized
Gains

 

 

Unrealized
Losses

 

 

Fair
Value

 

U.S. government treasury securities

 

$

87,887

 

 

$

3

 

 

$

-

 

 

$

87,890

 

Totals

 

$

87,887

 

 

$

3

 

 

$

-

 

 

$

87,890

 

 

 

 

December 31, 2020

 

(in thousands)

 

Amortized
Cost

 

 

Unrealized
Gains

 

 

Unrealized
Losses

 

 

Fair
Value

 

U.S. government treasury securities

 

$

233,687

 

 

$

-

 

 

$

(24

)

 

$

233,663

 

Totals

 

$

233,687

 

 

$

-

 

 

$

(24

)

 

$

233,663

 

 

Certain short-term debt securities with original maturities of less than 90 days are included in cash and cash equivalents on the condensed consolidated balance sheets and are not included in the tables above. At June 30, 2021 and December 31, 2020, all investments had contractual maturities within one year.

4. Fair Value Measurements

The following tables present information about the Company’s financial assets and liabilities measured at fair value on a recurring basis:

 

 

 

June 30, 2021

 

(in thousands)

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

Money market fund

 

$

192,431

 

 

$

-

 

 

$

-

 

 

$

192,431

 

Totals

 

$

192,431

 

 

$

-

 

 

$

-

 

 

$

192,431

 

Short-term investments:

 

 

 

 

 

 

 

 

 

 

 

 

U.S. government treasury securities

 

$

87,890

 

 

$

-

 

 

$

-

 

 

$

87,890

 

Totals

 

$

87,890

 

 

$

-