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 March 31, 2022

OR

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

For the transition period from _____________________ to _____________________

Commission File Number: 001-39397

 

INOZYME PHARMA, INC.

(Exact name of registrant as specified in its charter)

 

 

Delaware

38-4024528

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer
Identification No.)

321 Summer Street, Suite 400

Boston, Massachusetts

02210

(Address of principal executive offices)

(Zip Code)

 

Registrant’s telephone number, including area code: (857) 330-4340

 

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

 

INZY

 

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 May 6, 2022, the registrant had 40,097,076 shares of common stock, $0.0001 par value per share, outstanding.

 

 

 


 

FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements, which reflect our current views with respect to, among other things, our operations and financial performance. All statements, other than statements of historical fact, contained in this Quarterly Report on Form 10-Q, including statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth, are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “outlook,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would,” and the negative version of these words and other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Such forward-looking statements are subject to various risks and uncertainties. Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements. We believe these factors include but are not limited to those described in the “Risk Factors” section in our most recent Annual Report on Form 10-K and include, among other things:

our ongoing Phase 1/2 clinical trials of INZ-701 for ENPP1 and ABCC6 Deficiencies, including statements regarding the timing of enrollment and completion of the clinical trials and the period during which the results of the clinical trials will become available;
the timing and conduct of our planned later stage clinical trials of INZ-701 for patients with ENPP1 and ABCC6 Deficiencies;
our plans to conduct research and preclinical testing of INZ-701 for additional indications;
our plans to conduct research and preclinical testing of other product candidates;
the timing of, and our ability to obtain and maintain, marketing approvals of INZ-701, and the ability of INZ-701 and our other product candidates to meet existing or future regulatory standards;
our expectations regarding our ability to fund our operating expenses and capital expenditure requirements with our cash, cash equivalents and short-term investments;
the potential advantages of our product candidates;
the rate and degree of market acceptance and clinical utility of our product candidates;
our estimates regarding the potential market opportunity for our product candidates;
our commercialization and manufacturing capabilities and strategy;
our intellectual property position;
the impact of COVID-19 on our business and operations;
our ability to identify additional products, product candidates or technologies with significant commercial potential that are consistent with our commercial objectives;
our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;
the impact of government laws and regulations;
our competitive position; and
our expectations regarding the time during which we will be an emerging growth company under the Jumpstart our Business Startups Act of 2012.

We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. We have included important factors in the cautionary statements included in our most recent Annual Report on Form 10-K, particularly in the “Risk Factors” section, that we believe could cause actual results or events to differ materially from the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, collaborations, joint ventures or investments we may make or enter into.

You should read this Quarterly Report on Form 10-Q and the documents that we have filed as exhibits to 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. The forward-looking statements contained in this Quarterly Report on Form 10-Q are made as of the date of this Quarterly Report on Form 10-Q, and we do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

i


 

Table of Contents

 

 

 

Page

PART I.

FINANCIAL INFORMATION

1

Item 1.

Financial Statements (Unaudited)

1

 

Condensed Consolidated Balance Sheets

1

 

Condensed Consolidated Statements of Operations and Comprehensive Loss

2

 

Condensed Consolidated Statements of Stockholders’ Equity

3

 

Condensed Consolidated Statements of Cash Flows

4

 

Notes to Unaudited Condensed Consolidated Financial Statements

5

Item 2.

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

15

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

24

Item 4.

Controls and Procedures

25

PART II.

OTHER INFORMATION

26

Item 1A.

Risk Factors

26

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

26

Item 6.

Exhibits

27

Signatures

28

 

ii


 

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements (Unaudited)

INOZYME PHARMA, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(amounts in thousands, except share and per share data)

(Unaudited)

 

 

 

March 31,
2022

 

 

December 31,
2021

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

31,943

 

 

$

23,316

 

Short-term investments

 

 

65,830

 

 

 

88,485

 

Prepaid expenses and other current assets

 

 

2,810

 

 

 

3,541

 

Total current assets

 

 

100,583

 

 

 

115,342

 

Property and equipment, net

 

 

2,234

 

 

 

2,383

 

Right-of-use assets

 

 

1,950

 

 

 

2,053

 

Restricted cash

 

 

354

 

 

 

354

 

Prepaid expenses, net of current portion

 

 

3,810

 

 

 

3,409

 

Total assets

 

$

108,931

 

 

$

123,541

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

2,200

 

 

$

2,394

 

Accrued expenses

 

 

9,308

 

 

 

8,508

 

Operating lease liabilities

 

 

752

 

 

 

731

 

Total current liabilities

 

 

12,260

 

 

 

11,633

 

Operating lease liabilities, net of current portion

 

 

2,442

 

 

 

2,640

 

Total liabilities

 

 

14,702

 

 

 

14,273

 

Commitments and contingencies (Note 7)

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

Preferred Stock, $0.0001 par value – 5,000,000 shares authorized at March 31, 2022 and December 31, 2021; No shares issued and outstanding at March 31, 2022 or December 31, 2021

 

 

 

 

 

 

Common Stock, $0.0001 par value – 200,000,000 shares authorized at March 31, 2022 and December 31, 2021; 23,818,411 shares issued and outstanding at March 31, 2022 and 23,668,747 shares issued and outstanding at December 31, 2021

 

 

2

 

 

 

2

 

Additional paid in-capital

 

 

258,940

 

 

 

256,948

 

Accumulated other comprehensive (loss) income

 

 

(129

)

 

 

18

 

Accumulated deficit

 

 

(164,584

)

 

 

(147,700

)

Total stockholders’ equity

 

 

94,229

 

 

 

109,268

 

Total liabilities and stockholders’ equity

 

$

108,931

 

 

$

123,541

 

 

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

1


 

INOZYME PHARMA, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(amounts in thousands, except share and per share data)

(Unaudited)

 

 

 

Three Months Ended March 31,

 

 

 

2022

 

 

2021

 

Operating expenses:

 

 

 

 

 

 

Research and development

 

$

11,814

 

 

$

6,603

 

General and administrative

 

 

5,025

 

 

 

4,369

 

Total operating expenses

 

 

16,839

 

 

 

10,972

 

Loss from operations

 

 

(16,839

)

 

 

(10,972

)

Other income (expense):

 

 

 

 

 

 

Interest income

 

 

60

 

 

 

63

 

Other expenses

 

 

(105

)

 

 

(141

)

Other expenses, net

 

 

(45

)

 

 

(78

)

Net loss

 

$

(16,884

)

 

$

(11,050

)

Other comprehensive (loss) income:

 

 

 

 

 

 

Unrealized (losses) gains on available-for-sale securities

 

 

(132

)

 

 

10

 

Foreign currency translation adjustment

 

 

(15

)

 

 

 

Total other comprehensive (loss) income

 

 

(147

)

 

 

10

 

Comprehensive loss

 

$

(17,031

)

 

$

(11,040

)

Net loss attributable to common stockholders—basic
   and diluted

 

$

(16,884

)

 

$

(11,050

)

Net loss per share attributable to common
   stockholders—basic and diluted

 

$

(0.71

)

 

$

(0.47

)

Weighted-average common shares outstanding—basic
   and diluted

 

 

23,686,351

 

 

 

23,429,507

 

 

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

2


 

INOZYME PHARMA, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(amounts in thousands, except share data)

(Unaudited)

 

 

 

Common Stock

 

 

Additional
Paid-in

 

 

Accumulated
Other
Comprehensive

 

 

Accumulated

 

 

Total
Stockholders’
Equity

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Income (Loss)

 

 

Deficit

 

 

 

 

Balance at December 31, 2021

 

 

23,668,747

 

 

$

2

 

 

$

256,948

 

 

$

18

 

 

$

(147,700

)

 

$

109,268

 

Stock-based compensation

 

 

 

 

 

 

 

 

1,752

 

 

 

 

 

 

 

 

 

1,752

 

Exercise of stock options

 

 

149,664

 

 

 

 

 

 

240

 

 

 

 

 

 

 

 

 

240

 

Comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized loss on investments

 

 

 

 

 

 

 

 

 

 

 

(132

)

 

 

 

 

 

(132

)

Foreign currency translation adjustment

 

 

 

 

 

 

 

 

 

 

 

(15

)

 

 

 

 

 

(15

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(16,884

)

 

 

(16,884

)

Balance at March 31, 2022

 

 

23,818,411

 

 

$

2

 

 

$

258,940

 

 

$

(129

)

 

$

(164,584

)

 

$

94,229

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at December 31, 2020

 

 

23,384,969

 

 

$

2

 

 

$

249,175

 

 

$

2

 

 

$

(91,076

)

 

$

158,103

 

Stock-based compensation

 

 

 

 

 

 

 

 

1,577

 

 

 

 

 

 

 

 

 

1,577

 

Exercise of stock options

 

 

88,734

 

 

 

 

 

 

249

 

 

 

 

 

 

 

 

 

249

 

Comprehensive income:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain on investments

 

 

 

 

 

 

 

 

 

 

 

10

 

 

 

 

 

 

10

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(11,050

)

 

 

(11,050

)

Balance at March 31, 2021

 

 

23,473,703

 

 

$

2

 

 

$

251,001

 

 

$

12

 

 

$

(102,126

)

 

$

148,889

 

 

 

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

3


 

INOZYME PHARMA, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(amounts in thousands)

(Unaudited)

 

 

 

Three Months Ended
March 31,

 

 

 

2022

 

 

2021

 

Operating activities

 

 

 

 

 

 

Net loss

 

$

(16,884

)

 

$

(11,050

)

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

 

 

 

 

 

 

Depreciation and amortization

 

 

178

 

 

 

158

 

Stock-based compensation expense

 

 

1,752

 

 

 

1,577

 

Amortization of premiums and discounts on marketable securities

 

 

(76

)

 

 

58

 

Reduction in the carrying value of right-of-use assets

 

 

103

 

 

 

90

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

Prepaid expenses and other current assets

 

 

731

 

 

 

327

 

Accounts payable

 

 

(194

)

 

 

(1,373

)

Accrued expenses

 

 

808

 

 

 

(2,272

)

Operating lease liabilities

 

 

(177

)

 

 

(131

)

Prepaid expenses - noncurrent

 

 

(401

)

 

 

240

 

Net cash used in operating activities

 

 

(14,160

)

 

 

(12,376

)

Investing activities

 

 

 

 

 

 

Purchases of marketable securities

 

 

(30,421

)

 

 

(38,549

)

Maturities of marketable securities

 

 

53,000

 

 

 

39,210

 

Purchases of property and equipment

 

 

(17

)

 

 

(88

)

Net cash provided by investing activities

 

 

22,562

 

 

 

573

 

Financing activities

 

 

 

 

 

 

Proceeds from exercise of stock options

 

 

240

 

 

 

249

 

Net cash provided by financing activities

 

 

240

 

 

 

249

 

Net (decrease) increase in cash, cash equivalents and restricted cash

 

 

8,642

 

 

 

(11,554

)

Effect of foreign currency exchange rate in cash

 

 

(15

)

 

 

 

Cash, cash equivalents and restricted cash at beginning of period

 

 

23,670

 

 

 

28,394

 

Cash, cash equivalents and restricted cash at end of period

 

$

32,297

 

 

$

16,840

 

Supplemental cash flow information:

 

 

 

 

 

 

Cash and cash equivalents

 

$

31,943

 

 

$

16,486

 

Restricted cash

 

 

354

 

 

 

354

 

Cash, cash equivalents and restricted cash at end of period

 

$

32,297

 

 

$

16,840

 

Property and equipment unpaid at end of period

 

$

12

 

 

$

110

 

Right-of-use asset at adoption of Topic 842

 

$

 

 

$

2,431

 

Operating lease liabilities at adoption of Topic 842

 

$

 

 

$

3,997

 

 

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

4


Inozyme Pharma, Inc.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

 

1. Organization and Basis of Presentation

Inozyme Pharma, Inc. (the “Company”) is a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of diseases of abnormal mineralization impacting the vasculature, soft tissue and skeleton.

The Company is pursuing the development of therapeutics to address the underlying causes of these debilitating diseases. It is well established that two genes, ENPP1 and ABCC6, play key roles in a critical mineralization pathway and that defects in these genes lead to abnormal mineralization. The Company is initially focused on developing a novel therapy to treat rare genetic diseases of ENPP1 Deficiency and ABCC6 Deficiency.

The Company’s lead product candidate, INZ-701, is a soluble, recombinant, or genetically engineered, fusion protein that is designed to correct a defect in the mineralization pathway caused by ENPP1 and ABCC6 Deficiencies. This pathway is central to the regulation of calcium deposition throughout the body and is further associated with neointimal proliferation, or the overgrowth of smooth muscle cells inside blood vessels.

 

Basis of Presentation

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with United States generally accepted accounting principles ("U.S. GAAP") for interim financial information. Accordingly, these unaudited condensed consolidated financial statements do not include all of the information and note disclosures required by U.S. GAAP for audited year-end financial statements. The accompanying unaudited condensed consolidated financial statements reflect all normal recurring adjustments that are, in the opinion of management, necessary for a fair presentation of the interim period results. The results for the three months ended March 31, 2022 are not necessarily indicative of results to be expected for the year ending December 31, 2022, any other interim periods, or any future year or period. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company's Annual Report on Form 10-K for the year ended December 31, 2021. Any reference in these notes to applicable guidance is meant to refer to authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”).

Liquidity, Capital Resources, and Going Concern

Since the Company’s incorporation in 2017 and through March 31, 2022, the Company has devoted substantially all of its efforts to raising capital, building infrastructure, developing intellectual property and conducting research and development activities. The Company incurred net losses of $16.9 million in the three months ended March 31, 2022 and $56.6 million in the year ended December 31, 2021 and had an accumulated deficit of $164.6 million as of March 31, 2022. The Company had cash, cash equivalents, and short-term investments of $97.8 million as of March 31, 2022. Subsequent to March 31, 2022, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with Jefferies LLC and Cowen and Company, LLC , relating to an underwritten offering of 16,276,987 shares of the Company’s common stock (the "Shares") and, in lieu of common stock to certain investors, pre-funded warrants to purchase 3,523,013 shares of common stock. The closing of the offering took place on April 19, 2022. The offering price of the Shares was $3.69 per share and the offering price of the pre-funded warrants was $3.6899 per share underlying each pre-funded warrant. Net proceeds from the offering were approximately $68.3 million, after deducting underwriting discounts and commissions and estimated offering expenses.

The Company has incurred recurring losses and negative cash flows from operations since inception and has primarily funded its operations with proceeds from the issuance of convertible preferred stock and offerings of common stock and pre-funded warrants. The Company expects its operating losses and negative operating cash flows to continue into the foreseeable future as it continues to expand its research and development efforts.

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. The Company believes its available cash, cash equivalents, and short-term investments as of March 31, 2022, together with the net proceeds from its sale of common stock and pre-funded warrants in April 2022, will be sufficient to fund its operating expenses and capital expenditure requirements for at least twelve months from the date of filing this Quarterly Report on Form 10-Q. Management’s expectations with respect to its ability to fund current and long term planned operations are based on estimates that are subject to risks and uncertainties. If actual results are different from management’s estimates, the Company may need to seek additional strategic or financing

5


 

opportunities sooner than would otherwise be expected. However, there is no guarantee that any of these strategic or financing opportunities will be executed on favorable terms, or at all, and some could be dilutive to existing stockholders. If the Company is unable to obtain additional funding on a timely basis, it may be forced to delay, reduce or eliminate some or all of its research and development programs, portfolio expansion or commercialization efforts, which could adversely affect its business.

2. Summary of Significant Accounting Policies

 

Principles of Consolidation

The accompanying consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries, Inozyme Securities Corp., which is a Massachusetts subsidiary created to buy, sell, and hold securities, Inozyme Ireland Limited, and Inozyme Pharma Switzerland GmbH. All intercompany transactions and balances have been eliminated.

Summary of Significant Accounting Policies

The significant accounting policies and estimates used in the preparation of the accompanying consolidated financial statements are described in the Company’s audited consolidated financial statements for the year ended December 31, 2021 included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021. There have been no material changes in the Company’s significant accounting policies during the three months ended March 31, 2022.

Use of Estimates

The preparation of the Company’s financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Estimates and judgments are based on historical information and other market-specific or various relevant assumptions, including, in certain circumstances, future projections that management believes to be reasonable under the circumstances. Actual results could differ materially from estimates. Significant estimates and assumptions are used for, but not limited to, the accruals for research and development expenses. The Company evaluates its estimates and assumptions on an ongoing basis. All revisions to accounting estimates are recognized in the period in which the estimates are revised and in any future periods affected.

 

Accrued Research and Development Costs

The Company records accrued liabilities for estimated costs of research and development activities conducted by service providers for sponsored research, preclinical studies, clinical trials, and contract manufacturing activities. The Company records the estimated costs of research and development activities based upon the estimated amount of services provided but not yet invoiced and includes these costs in accrued expenses in the accompanying consolidated balance sheets and within research and development expense in the accompanying consolidated statements of operations and comprehensive loss.

The Company accrues for these costs based on factors such as estimates of the work completed and in accordance with agreements established with service providers. The Company makes significant judgments and estimates in determining the accrued liabilities balance in each reporting period. As actual costs become known, the Company adjusts its accrued liabilities. The Company has not experienced any material differences between accrued costs and actual costs incurred since its inception.

Research and Development Costs

Research and development costs are expensed as incurred. Research and development costs consist of direct and indirect internal costs related to specific projects as well as fees paid to other entities that conduct certain research and development activities on the Company’s behalf.

 

Net Loss Per Share

 

The Company follows the two-class method when computing net loss allocable to common securities per share as the Company had previously issued shares that meet the definition of participating securities. The two-class method requires a portion of net income to be allocated to the participating securities to determine net income allocable to the common securities. 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.

 

6


 

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 shares of common stock outstanding during the period, without consideration for potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of shares of common stock and potentially dilutive securities outstanding using the treasury-stock and if-converted methods. The Company has generated a net loss in all periods presented, therefore 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.

 

Fair Value Measurements

 

The Company categorizes its assets and liabilities measured at fair value in accordance with the authoritative accounting guidance that establishes a consistent framework for measuring fair value and expands disclosures for each major asset and liability category measured at fair value on either a recurring or nonrecurring basis. Fair value is defined as the exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows:

 

Level 1- Unadjusted quoted prices in active markets that are accessible at the measurement date for identical assets or liabilities;
Level 2- Quoted prices for similar assets and liabilities in active markets, quoted prices in markets that are not active, or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liability; or
Level 3- Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e., supported by little or no market activity).

Concentration of Credit Risk and Off-Balance Sheet Risk

Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents and short-term investments and, from time to time, long-term investments. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits and limits its exposure to credit risk by placing its cash with high credit quality financial institutions. The Company’s investments are comprised of U.S. Treasury securities and commercial paper of corporations. The Company mitigates credit risk by maintaining a diversified portfolio and limiting the amount of investment exposure as to institution, maturity and investment type.

The Company has no significant off-balance sheet risk such as foreign exchange contracts, option contracts, or other foreign hedging arrangements.

 

3. Recent Accounting Pronouncements

From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies that are adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption.

Recently Issued and Adopted Accounting Standards

In December 2019, the FASB issued ASU 2019-12, Income Taxes – Simplifying the Accounting for Income Taxes. The new guidance simplifies the accounting for income taxes by removing several exceptions in the current standard and adding guidance to reduce complexity in certain areas, such as requiring that an entity reflect the effect of an enacted change in tax laws or rates in the annual effective tax rate computation in the interim period that includes the enactment date. The new standard is effective for fiscal years beginning after December 15, 2021, and interim periods within fiscal years beginning after December 15, 2022 for non-public entities, with early adoption permitted. The Company adopted this standard effective January 1, 2022. There was no material impact to the Company's financial statements upon adoption.

Recently Issued Accounting Standards Not Yet Adopted

In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. ASU 2016-13 and its subsequent related updates establish a new forward-looking “expected loss model” that requires entities to estimate current expected credit losses on accounts receivable and financial instruments by using

7


 

all practical and relevant information. The new standard and its subsequent related updates are effective for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years, with early adoption permitted. The Company is currently assessing the impact that adopting this standard will have on its consolidated financial statements but does not expect it to be material.

4. Balance Sheet Details

Short-term investments consisted of the following (dollar amounts in thousands):

 

 

 

March 31, 2022

 

Description

 

Maturity

 

Amortized
Costs

 

 

Gross
Unrealized
Gains

 

 

Gross
Unrealized
Losses

 

 

Estimated
Fair Value

 

Commercial paper

 

1 year or less

 

$

44,213

 

 

$

 

 

$

(87

)

 

$

44,126

 

U.S. Treasury securities

 

1 year or less

 

 

21,747

 

 

 

 

 

 

(43

)

 

 

21,704

 

 

 

 

 

$

65,960

 

 

$

 

 

$

(130

)

 

$

65,830

 

 

 

 

December 31, 2021

 

Description

 

Maturity

 

Amortized
Costs

 

 

Gross
Unrealized
Gains

 

 

Gross
Unrealized
Losses

 

 

Estimated
Fair Value

 

Commercial paper

 

1 year or less

 

$

78,456

 

 

$

5

 

 

$

(3

)

 

$

78,458

 

U.S. Treasury securities

 

1 year or less

 

 

5,025

 

 

 

 

 

 

 

 

 

5,025

 

U.S. government agency debt securities

 

1 year or less

 

 

5,002

 

 

 

 

 

 

 

 

 

5,002

 

 

 

 

 

$

88,483

 

 

$

5

 

 

$

(3

)

 

$

88,485

 

 

The Company concluded that the declines in market value of available-for-sale securities were temporary in nature and did not consider any of the investments to be other-than-temporarily impaired. In accordance with its investment policy, the Company invests in investment grade securities with high credit quality issuers, and generally limits the amount of credit exposure to any one issuer. The Company evaluates securities for other-than-temporary impairment at the end of each reporting period. Impairment is evaluated considering numerous factors, and their relative significance varies depending on the situation. Factors considered include the length of time and extent to which fair value has been less than the cost basis, the financial condition and near-term prospects of the issuer, and the Company’s intent and ability to hold the investment to allow for an anticipated recovery in fair value. Furthermore, the aggregate of individual unrealized losses that had been outstanding for 12 months or less was not significant as of March 31, 2022 and December 31, 2021. The Company does not intend to sell these investments and it is not more likely than not that the Company will be required to sell the investments before a recovery of their amortized cost bases, which may be maturity. The Company also believes that it will be able to collect both principal and interest amounts due at maturity.

Prepaid expenses and other current assets consisted of the following (dollar amounts in thousands):

 

 

 

At March 31,
2022

 

 

At December 31,
2021

 

Interest receivable

 

$

48

 

 

$

62

 

Prepaid insurance

 

 

1,029

 

 

 

1,728

 

Prepaid research studies

 

 

1,014

 

 

 

1,190

 

Prepaid other

 

 

719

 

 

 

561

 

Total

 

$

2,810

 

 

$

3,541

 

 

Prepaid expenses, net of current portion, consisted of the following (dollar amounts in thousands):

 

 

 

At March 31,
2022

 

 

At December 31,
2021

 

Prepaid clinical trial and other

 

$

3,810

 

 

$

3,409

 

 

 

$

3,810

 

 

$

3,409

 

 

8


 

 

Property and equipment consisted of the following (dollar amounts in thousands):

 

 

 

At March 31,
2022

 

 

At December 31,
2021

 

Laboratory equipment and manufacturing equipment

 

$

591

 

 

$

591

 

Furniture and fixtures

 

 

258

 

 

 

258

 

Computer equipment and software

 

 

469

 

 

 

440

 

Leasehold improvements

 

 

2,095

 

 

 

2,095

 

 

 

 

3,413

 

 

 

3,384

 

Less accumulated depreciation

 

 

(1,179

)

 

 

(1,001

)

Total

 

$

2,234

 

 

$

2,383

 

 

Depreciation expense for the three months ended March 31, 2022 and 2021 was $178 thousand and $158 thousand, respectively.

Accrued expenses consisted of the following (dollar amounts in thousands):

 

 

 

At March 31,
2022

 

 

At December 31,
2021

 

Payroll and related liabilities

 

$

750

 

 

$

2,379

 

Professional fees

 

 

590

 

 

 

727

 

Research and development costs

 

 

7,144

 

 

 

5,066

 

Other

 

 

824

 

 

 

336

 

Total

 

$

9,308

 

 

$

8,508

 

 

5. Fair Value Measurement

The following table represents the Company’s financial assets measured at fair value on a recurring basis and indicate the level of fair value hierarchy utilized to determine such fair values (in thousands):

 

 

 

 

 

 

Fair Value Measurements at Reporting Date
Using

 

Description

 

March 31,
2022

 

 

Quoted
Prices in
Active
Markets for
Identical
Assets
(Level 1)

 

 

Significant
Other
Observable
Inputs
(Level 2)

 

 

Significant
Unobservable
Inputs
(Level 3)

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds (included in cash and cash
   equivalents)

 

$

21,877

 

 

$

21,877

 

 

$

 

 

$

 

Commercial paper

 

 

44,126

 

 

 

 

 

 

44,126

 

 

 

 

U.S. Treasury securities

 

 

21,704