10-Q 1 pmvp-10q_20220331.htm 10-Q pmvp-10q_20220331.htm
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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: 001-39539

 

PMV PHARMACEUTICALS, INC.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware

46-3218129

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification No.)

8 Clarke Drive, Suite 3

Cranbury, NJ

08512

(Address of principal executive offices)

(Zip Code)

 

Registrant’s telephone number, including area code: (609) 642-6670

 

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 $0.00001

 

PMVP

 

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  

Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Sections 12, 13 or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court.     Yes      No  

As of May 8, 2022, the registrant had 45,574,075 shares of common stock, $0.00001 par value per share, outstanding.

 

 


 

Table of Contents

 

 

 

Page

PART I.

FINANCIAL INFORMATION

1

Item 1.

Condensed Financial Statements (Unaudited)

1

 

Condensed Balance Sheets (Unaudited)

1

 

Condensed Statements of Operations and Comprehensive Loss (Unaudited)

2

 

Condensed Statements of Stockholders’ Equity (Unaudited)

3

 

Condensed Statements of Cash Flows (Unaudited)

4

 

Notes to Unaudited Condensed Financial Statements

5

Item 2.

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

13

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

20

Item 4.

Controls and Procedures

20

PART II.

OTHER INFORMATION

21

Item 1.

Legal Proceedings

21

Item 1A.

Risk Factors

21

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

22

Item 3.

Defaults Upon Senior Securities

22

Item 4.

Mine Safety Disclosures

22

Item 5.

Other Information

22

Item 6.

Exhibits

23

Signatures

25

 

 

 

i


 

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements that involve risks and uncertainties. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. All statements other than statements of historical facts contained in this Quarterly Report on Form10-Q, including statements regarding our future results of operations and financial position, business strategy, development plans, planned preclinical studies and clinical trials, future results of clinical trials, expected research and development costs, regulatory strategy, timing and likelihood of success, as well as plans and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “would,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. Forward-looking statements contained in this Quarterly Report on Form 10-Q include, but are not limited to, statements about:

 

our financial performance;

 

the sufficiency of our existing cash, cash equivalents and short-term marketable securities to fund our future operating expenses and capital expenditure requirements;

 

our need to raise additional funding before we can expect to generate any revenues from product sales;

 

our ability to obtain additional funding for our operations, when needed, including funding necessary to complete further development and commercialization of our product candidates, if approved;

 

the accuracy of our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;

 

the implementation of our strategic plans for our business and product candidates;

 

the size of the market opportunity for our product candidates and our ability to maximize those opportunities;

 

the initiation, timing, progress and results of our research and development programs, preclinical studies, clinical trials and investigational new drug applications, or IND, and other regulatory submissions;

 

the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates;

 

our estimates of the number of patients for each of our programs including patients expected to have certain p53 mutations and the number of patients that will enroll in our clinical trials;

 

the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other favorable results;

 

our plans relating to the clinical development of our product candidates, including the disease areas to be evaluated;

 

the timing, progress and focus of our clinical trials, and the reporting of data from those trials;

 

our ability to obtain and maintain regulatory approval of our product candidates;

 

our plans relating to commercializing our product candidates, if approved;

 

the expected benefits of potential future strategic collaborations with third parties and our ability to attract collaborators with development, regulatory and commercialization expertise;

 

the success of competing therapies that are or may become available;

 

the timing or likelihood of regulatory filings and approvals, including our expectation to seek accelerated reviews or special designations, such as breakthrough therapy and orphan drug designation, for our product candidates;

 

our plans relating to the further development and manufacturing of our product candidates, including for additional indications that we may pursue;

 

existing regulations and regulatory developments in the United States and other jurisdictions;

 

our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available;

 

our plans to rely on third parties to conduct and support preclinical and clinical development;

ii


 

 

our ability to retain the continued service of our key personnel and to identify, hire and then retain additional qualified personnel; and

 

the impact of the ongoing coronavirus disease 2019, or COVID-19, pandemic, or other potential global disruptions on our business, such as the recent conflict between Russia and Ukraine and the trade sanctions imposed in response thereto

We have based these forward-looking statements largely on our current expectations and projections about our business, the industry in which we operate and financial trends that we believe may affect our business, financial condition, results of operations and prospects, and these forward-looking statements are not guarantees of future performance or development. These forward-looking statements speak only as of the date of this Quarterly Report on Form 10-Q and are subject to a number of risks, uncertainties and assumptions described in the section titled “Item 1A. Risk Factors” and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2021, as well as in this Quarterly Report on Form 10-Q. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. 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 or otherwise.

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 Quarterly Report on Form 10-Q, 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 you are cautioned not to unduly rely upon these statements.

 

 

iii


 

PART I—FINANCIAL INFORMATION

Item 1. Condensed Financial Statements (Unaudited).

PMV Pharmaceuticals, Inc.

Condensed Balance Sheets

(unaudited)

(in thousands, except share and per share amounts)

 

 

 

March 31,

2022

(unaudited)

 

 

December 31,

2021

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

115,772

 

 

$

172,467

 

Restricted cash

 

 

822

 

 

 

822

 

Marketable securities, current

 

 

167,221

 

 

 

124,696

 

Prepaid expenses and other current assets

 

 

4,225

 

 

 

3,301

 

Total current assets

 

 

288,040

 

 

 

301,286

 

Property and equipment, net

 

 

5,238

 

 

 

3,090

 

Marketable securities, noncurrent

 

 

11,773

 

 

 

16,911

 

Right-of-use assets, operating leases

 

 

9,736

 

 

 

10,060

 

Other assets

 

 

221

 

 

 

221

 

Total assets

 

$

315,008

 

 

$

331,568

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

4,864

 

 

$

3,189

 

Accrued expenses

 

 

6,563

 

 

 

8,627

 

Operating lease liability, current

 

 

258

 

 

 

403

 

Total current liabilities

 

 

11,685

 

 

 

12,219

 

Operating lease liability, noncurrent

 

 

11,480

 

 

 

10,790

 

Total liabilities

 

 

23,165

 

 

 

23,009

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

Preferred stock, $0.00001 par value, 5,000,000 shares authorized at March 31,

   2022 (unaudited) and December 31, 2021.  No shares issued or outstanding at

   March 31, 2022 (unaudited) and December 31, 2021.

 

 

 

 

 

 

Common stock, $0.00001 par value, 1,000,000,000 shares authorized;

   45,532,392 and 45,433,684 shares issued and outstanding at March 31, 2022

   (unaudited) and December 31, 2021, respectively.

 

 

 

 

 

 

Additional paid-in capital

 

 

478,668

 

 

 

476,363

 

Accumulated deficit

 

 

(186,159

)

 

 

(167,726

)

Accumulated other comprehensive loss

 

 

(666

)

 

 

(78

)

Total stockholders’ equity

 

 

291,843

 

 

 

308,559

 

Total liabilities and stockholders’ equity

 

$

315,008

 

 

$

331,568

 

 

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

1


PMV Pharmaceuticals, Inc.

Condensed Statements of Operations and Comprehensive Loss

(unaudited)

(in thousands, except share and per share amounts)

 

 

 

Three Months Ended March 31,

 

 

 

2022

 

 

2021

 

Operating expenses:

 

 

 

 

 

 

 

 

Research and development

 

$

11,836

 

 

$

7,500

 

General and administrative

 

 

6,783

 

 

 

4,174

 

Total operating expenses

 

 

18,619

 

 

 

11,674

 

Loss from operations

 

 

(18,619

)

 

 

(11,674

)

Other income (expense):

 

 

 

 

 

 

 

 

Interest income, net

 

 

229

 

 

 

128

 

Other expense

 

 

(41

)

 

 

(52

)

Total other income (expense)

 

 

188

 

 

 

76

 

Loss before provision for income taxes

 

 

(18,431

)

 

 

(11,598

)

Provision for income taxes

 

 

2

 

 

 

4

 

Net loss

 

 

(18,433

)

 

 

(11,602

)

Unrealized loss on marketable securities, net of tax

 

 

(588

)

 

 

(13

)

Comprehensive loss

 

$

(19,021

)

 

$

(11,615

)

 

 

 

 

 

 

 

 

 

Net loss per share -- basic and diluted

 

$

(0.41

)

 

$

(0.26

)

Weighted-average common shares outstanding

 

 

45,466,044

 

 

 

44,785,226

 

 

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

 

 

2


 

PMV Pharmaceuticals, Inc.

Condensed Statements of Stockholders’ Equity

(unaudited)

(in thousands, except share amounts)

 

 

 

Common Stock

 

 

Additional

Paid-in

 

 

Accumulated

Other

Comprehensive

 

 

Accumulated

 

 

Total

Stockholders'

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Loss

 

 

Deficit

 

 

Equity

 

Balance at December 31, 2020

 

 

44,777,818

 

 

$

 

 

$

469,001

 

 

$

 

 

$

(109,880

)

 

$

359,121

 

Exercise of stock options

 

 

103,351

 

 

 

 

 

 

 

162

 

 

 

 

 

 

 

 

 

 

 

162

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

627

 

 

 

 

 

 

 

 

 

627

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(11,602

)

 

 

(11,602

)

Unrealized loss on available for sale investments

 

 

 

 

 

 

 

 

 

 

 

(13

)

 

 

 

 

 

(13

)

Balance at March 31, 2021

 

 

44,881,169

 

 

$

 

 

$

469,790

 

 

$

(13

)

 

$

(121,482

)

 

$

348,295

 

 

 

 

Common Stock

 

 

Additional

Paid-in

 

 

Accumulated

Other

Comprehensive

 

 

Accumulated

 

 

Total

Stockholders'

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Loss

 

 

Deficit

 

 

Equity

 

Balance at December 31, 2021

 

 

45,433,684

 

 

$

 

 

$

476,363

 

 

$

(78

)

 

$

(167,726

)

 

$

308,559

 

Exercise of stock options and common stock issued under the 2020 ESPP

 

 

98,708

 

 

 

 

 

 

128

 

 

 

 

 

 

 

 

 

128

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

2,177

 

 

 

 

 

 

 

 

 

2,177

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(18,433

)

 

 

(18,433

)

Unrealized loss on available for sale investments

 

 

 

 

 

 

 

 

 

 

 

(588

)

 

 

 

 

 

(588

)

Balance at March 31, 2022

 

 

45,532,392

 

 

$

 

 

$

478,668

 

 

$

(666

)

 

$

(186,159

)

 

$

291,843

 

 

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

 

3


 

PMV Pharmaceuticals, Inc.

Condensed Statements of Cash Flows

(unaudited)

(in thousands)

 

 

 

Three Months Ended March 31,

 

 

 

2022

 

 

2021

 

Cash flows from operating activities:

 

 

 

 

 

 

 

 

Net loss

 

$

(18,433

)

 

$

(11,602

)

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

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

2,177

 

 

 

627

 

Depreciation

 

 

84

 

 

 

79

 

Amortization of premiums on marketable securities

 

 

54

 

 

 

167

 

Non-cash lease expense

 

 

83

 

 

 

 

Change in operating assets and liabilities:

 

 

 

 

 

 

 

 

Prepaid expenses and other assets

 

 

(924

)

 

 

(948

)

Operating lease right-of-use assets and liabilities

 

 

786

 

 

 

 

Accounts payable

 

 

239

 

 

 

(355

)

Accrued expenses

 

 

(2,064

)

 

 

(872

)

Net cash used in operating activities

 

 

(17,998

)

 

 

(12,904

)

Cash flows from investing activities:

 

 

 

 

 

 

 

 

Purchase of property and equipment

 

 

(796

)

 

 

(120

)

Purchase of marketable securities

 

 

(93,705

)

 

 

(139,777

)

Maturities of marketable securities

 

 

55,676

 

 

 

 

Net cash (used in) investing activities

 

 

(38,825

)

 

 

(139,897

)

Cash flows from financing activities:

 

 

 

 

 

 

 

 

Proceeds from exercise of stock options

 

 

128

 

 

 

162

 

Net cash provided by financing activities

 

 

128

 

 

 

162

 

Net decrease in cash and cash equivalents

 

 

(56,695

)

 

 

(152,639

)

Cash, cash equivalents, and restricted cash

 

 

 

 

 

 

 

 

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

 

 

173,289

 

 

 

361,422

 

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

 

$

116,594

 

 

$

208,783

 

Supplemental disclosures of noncash investing activities

 

 

 

 

 

 

 

 

Accrued purchases of property and equipment

 

$

1,436

 

 

$

-

 

Supplemental disclosures of cash flow information

 

 

 

 

 

 

 

 

Cash paid for income taxes

 

$

2

 

 

$

4

 

 

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

 

 

4


 

 

PMV Pharmaceuticals, Inc.

Notes to Condensed Financial Statements

(unaudited)

(in thousands, except share and per share amounts)

1. Formation and Business of the Company

Organization and Liquidity

PMV Pharmaceuticals, Inc. (the “Company” or “We”) was incorporated in the state of Delaware in March 2013. Since inception, the Company has devoted substantially all of its time and efforts to performing research and development activities and raising capital. We are a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53. The Company’s headquarters are located at 8 Clarke Drive, Suite 3, Cranbury, New Jersey.

The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry including, but not limited to, technical risks associated with the successful research, development and manufacturing of product candidates, 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. Current and future programs will require significant research and development efforts, including extensive preclinical and clinical testing and regulatory approval prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel, and infrastructure. 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 Company has incurred net losses and negative cash flows from operations since its inception. During the three months ended March 31, 2022, the Company incurred a net loss of $18,433 and used $17,998 of cash for operations. As of March 31, 2022, the Company had an accumulated deficit of $186,159. Cash, cash equivalents, and marketable securities were $294,766 as of March 31, 2022. Management expects to incur substantial additional operating losses for the next several years and may need to obtain additional debt or equity financings in order to complete development of its products, obtain regulatory approvals, launch and commercialize its products and continue research and development programs.  The Company believes it has adequate cash, cash equivalents, and marketable securities to operate for at least the next twelve months from the date of issuance of these financial statements.

2. Summary of Significant Accounting Policies

The Company’s significant accounting policies are disclosed in the audited financial statements for the year ended December 31, 2021, included in the Company’s Annual Report on Form 10-K filed with the United States Securities and Exchange Commission (the “SEC”) on March 1, 2022. Since the date of those financial statements, there have been no changes to its significant accounting policies except as noted below.

Basis of Presentation

The accompanying unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial information and with the interim period reporting requirements of Form 10-Q and Article 10 of Regulation S-X. The condensed balance sheet as of March 31, 2022, the condensed statements of operations and comprehensive loss, and condensed statements of stockholders’ equity for the three months ended March 31, 2022 and 2021, and the condensed statements of cash flows for the three months ended March 31, 2022 and 2021 are unaudited, but, in the opinion of management, include all adjustments, consisting only of normal recurring adjustments, which we consider necessary for a fair presentation of the financial position, operating results and cash flows for the periods presented.  The results for any interim period are not necessarily indicative of results for the year ending December 31, 2022, or for any other subsequent interim period.  The condensed balance sheet as of December 31, 2021, has been derived from our audited financial statements.

Use of Estimates

The preparation of financial statements in conformity with GAAP 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 reported amounts of revenues and expenses during the reporting period. The Company bases its estimates and assumptions on historical experience when available and on various factors that it believes to be reasonable under the circumstances. Significant estimates and assumptions reflected in these financial statements include, but

5


 

are not limited to, research and development costs, accrued research and development costs and related prepaid expenses and stock-based compensation. Actual results could differ materially from those estimates.

The length of time and full extent to which the COVID-19 pandemic directly or indirectly impacts our business, results of operations and financial condition, including expense, the supply chain, clinical trials, research and development costs, and employee-related costs, depends on future developments that are highly uncertain, subject to change and are difficult to predict, including as a result of new information that may emerge concerning COVID-19 and the actions taken to contain or treat COVID-19 as well as the economic impact on local, regional, national and international customers and markets.

Cash, Cash Equivalents and Marketable Securities

Management considers all highly liquid investments with original maturities of three months or less to be cash equivalents.

The Company’s marketable debt securities have been classified and accounted for as available-for-sale. The Company classifies its marketable debt securities as either short-term or long-term based on each instrument’s underlying contractual maturity date. Marketable debt securities with maturities of 12 months or less are classified as short-term and marketable debt securities with maturities greater than 12 months are classified as long-term. As of March 31, 2022, the company’s long-term marketable debt securities have maturity dates no more than 2 years. The Company’s marketable debt securities are carried at fair value, with unrealized gains and losses, net of taxes, reported as a component of accumulated other comprehensive loss in stockholders’ equity. Premiums and discounts on marketable debt securities are amortized into earnings over the life of the security. For the three months ended March 31, 2022, and 2021, the Company recorded $54 and $167 of amortization, respectively.

Restricted cash as of March 31, 2022, included a $822 deposit at the Company’s commercial bank underlying a stand-by letter of credit issued in favor of a landlord (See Note 6) and is classified in current assets.    

Comprehensive Loss

The Company presents comprehensive loss in a single statement within its financial statements. Other comprehensive loss consists of unrealized gains and losses on marketable securities, net of tax.

Leases

At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the circumstances present. The Company accounts for a contract as a lease when it has the right to control the asset for a period of time while obtaining substantially all of the asset’s economic benefits. The Company determines the initial classification and measurement of its operating right-of-use (“ROU”) assets and operating lease liabilities at the lease commencement date, and thereafter if modified. The lease term includes any renewal options that the Company is reasonably assured to exercise. The Company’s policy is to not record leases with a lease term of 12 months or less on its balance sheets. The Company’s only existing leases are for office and laboratory space.

The ROU asset represents the right to use the leased asset for the lease term. The lease liability represents the present value of the lease payments under the lease. The present value of lease payments is determined by using the interest rate implicit in the lease, if that rate is readily determinable; otherwise, the Company uses its estimated secured incremental borrowing rate for that lease term.

Lease expense for operating leases is recognized on a straight-line basis over the reasonably assured lease term based on the total lease payments and is included in operating expense in the statements of operations.

Payments due under each lease agreement include fixed and variable payments. Variable payments relate to the Company’s share of the lessor’s operating costs associated with the underlying asset and are recognized when the event on which those payments are assessed occurs. Neither of the Company’s leases contain residual value guarantees.

The interest rate implicit in lease agreements is typically not readily determinable, and as such, the Company utilizes the incremental borrowing rate to calculate lease liabilities, which is the rate incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment.

6


 

Concentration of Credit Risk and Other Risks and Uncertainties

Financial instruments that potentially subject the Company to significant concentrations of credit risk consist of cash and cash equivalents and marketable securities. Cash and cash equivalents include a checking account and a money market account held at one financial institution. At times, such deposits may be in excess of insured limits. The Company has not experienced any losses on its deposits of cash and cash equivalents. The Company’s marketable debt securities are carried at fair value and include any unrealized gains and losses. Any investments with unrealized losses are considered to be temporarily impaired.

The Company’s future results of operations involve a number of risks and uncertainties. Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations include, but are not limited to, rapid technological change, uncertainty of market acceptance of the product, competition from substitute products and larger companies, protection of proprietary technology, any future strategic relationships and dependence on key individuals.

Products developed by the Company require clearances from the U.S. Food and Drug Administration or other international regulatory agencies prior to commercial sales. There can be no assurance the Company’s product candidates will receive the necessary clearances. If the Company is denied clearance, clearance is delayed or it is unable to maintain clearance, it could have a materially adverse impact on the Company.

In January 2020, the World Health Organization declared the outbreak of a novel coronavirus (COVID-19) as a “Public Health Emergency of International Concern,” which continues to spread throughout the world. The outbreak has adversely impacted global commercial activity and contributed to significant volatility in financial markets. The COVID-19 outbreak and government responses are creating disruption in global supply chains and adversely impacting many industries. The outbreak could have a continued material adverse impact on economic and market conditions. The Company continues to monitor the impact of the COVID-19 outbreak closely. The full extent to which the COVID-10 outbreak will impact its operations or financial results remains uncertain.

3. Fair Value Measurements

The Company’s financial assets consist of money market funds, U.S. government debt securities and corporate debt securities. The following tables show the Company’s cash equivalents and available-for-sale securities’ carrying amounts and fair values as of March 31, 2022, and December 31, 2021:

 

 

 

As of March 31, 2022

 

 

 

Carrying

Amount

 

 

Gross Unrealized Gains

 

 

Gross Unrealized Losses

 

 

Fair

Value

 

 

Quoted

priced in

active

markets

(Level 1)

 

 

Significant

other

observable

inputs

(Level 2)

 

 

Significant

unobservable

inputs

(Level 3)

 

Financial assets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

38,484

 

 

$

 

 

$

 

 

$

38,484

 

 

$

38,484

 

 

$

 

 

$

 

Corporate securities

 

 

202,605

 

 

 

3

 

 

 

(288

)

 

 

202,320

 

 

 

 

 

 

202,320

 

 

 

 

Government securities

 

 

52,845

 

 

 

1

 

 

 

(382

)

 

 

52,464

 

 

 

38,768

 

 

 

13,696

 

 

 

 

Total financial assets

 

$

293,934

 

 

$

4

 

 

$

(670

)

 

$

293,268

 

 

$

77,252

 

 

$

216,016

 

 

$

 

 

 

 

As of December 31, 2021

 

 

 

Carrying

Amount

 

 

Gross Unrealized Gains

 

 

Gross Unrealized Losses

 

 

Fair

Value

 

 

Quoted

Priced in

Active

Markets

(Level 1)

 

 

Significant

Other

Observable

Inputs

(Level 2)

 

 

Significant

Unobservable

Inputs

(Level 3)

 

Financial assets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

40,960

 

 

$

 

 

$

 

 

$

40,960

 

 

$

40,960

 

 

$

 

 

$

 

Corporate securities

 

 

227,378

 

 

 

3

 

 

 

(19

)

 

 

227,362

 

 

 

 

 

 

227,362

 

 

 

 

Government securities

 

 

42,307

 

 

 

 

 

 

(62

)

 

 

42,245

 

 

 

 

 

 

42,245

 

 

 

 

Total financial assets

 

$

310,645

 

 

$

3

 

 

$

(81

)

 

$

310,567

 

 

$

40,960

 

 

$

269,607

 

 

$

 

 

Cash Equivalents — As of March 31, 2022, the Company had cash of $1,498 and cash equivalents of $114,274. Cash equivalents consisted of money market funds of $38,484 and corporate debt securities of $75,790. As of December 31, 2021, the Company had cash of $3,508 and cash equivalents of $168,960. Cash equivalents consisted of money market funds of $40,960 and corporate debt securities of $128,000. Money market funds are classified within level 1 of the fair value hierarchy because they are valued using quoted market prices in active markets, whereas corporate debt securities are classified within

7


 

level 2 of the fair value hierarchy because they are valued using inputs other than quoted prices that are observable for the asset or liability either directly or indirectly.

Marketable Securities — Marketable securities of $178,994 as of March 31, 2022, consisted of corporate debt securities of $126,530 and government debt securities of $52,464. There were $167,221 current marketable securities and $11,773 noncurrent marketable securities as of March 31, 2022. Marketable securities of $141,607 as of December 31, 2021, consisted of corporate debt securities of $99,362 and government debt securities of $42,245. There were $124,696 current marketable securities and $16,911 noncurrent marketable securities as of December 31, 2021.

As of March 31, 2022, and December 31, 2021, aggregated gross unrealized losses of available-for-sale investments were not material, and accordingly, no allowance for credit losses was recorded.

 

 

4. Property and Equipment, Net

 

 

 

March 31,

2022

 

 

December 31,

2021

 

Machinery & equipment

 

$

2,261

 

 

$

2,261

 

Computers

 

 

13

 

 

 

8

 

Furniture & fixtures

 

 

69

 

 

 

9

 

Leasehold improvements

 

 

409

 

 

 

161

 

Assets not placed in service

 

 

4,438

 

 

 

2,519

 

Total property and equipment

 

 

7,190

 

 

 

4,958

 

Less: Accumulated depreciation

 

 

(1,952

)

 

 

(1,868

)

Property and equipment, net

 

$

5,238

 

 

$

3,090

 

 

Depreciation expense for the three months ended March 31, 2022, and 2021 was $84 and $79, respectively. 

5. Accrued Expenses

Accrued expenses consist of the following:

 

 

 

March 31,

2022

 

 

December 31,

2021

 

Accrued compensation

 

$

1,759

 

 

$

3,797

 

Accrued legal and professional services

 

 

280

 

 

 

 

Accrued research and development costs

 

 

4,471

 

 

 

4,734

 

Other accrued liabilities

 

 

53

 

 

 

96

 

Total

 

$

6,563

 

 

$

8,627

 

 

 

6. Commitments and Contingencies

 

Operating Leases

In June 2015, the Company executed a noncancelable operating lease for approximately 13,000 square feet of laboratory, research and development, and office space in Cranbury, New Jersey for an initial base rent of $20.00 per square foot. This location operates as the Company’s current headquarters.

In June 2017, the Company obtained an additional noncancelable operating lease for about 6,000 square feet of laboratory space in the same corporate center at an initial rental rate at $22.00 per square foot. As a result of the additional space, both leases will expire June 2022, with an option to renew on a month-to-month basis, with an increase in base rent as per the lease, for up to an additional year. Both leases include a common area maintenance expense for $3.00 per square foot with an increase of 3% on the first month of each calendar year during the lease term and a management fee of 3% of the base rent. The Company is obligated to pay, on a pro-rata basis, real estate taxes and operating costs related to the premises.

8


 

In August 2018, the Company executed two noncancelable operating leases. One lease for approximately 6,000 square feet for vivarium, laboratory and general office space in South Brunswick, New Jersey. The initial annual base rent is $15.50 per square foot and a management fee of 3% of the base rent. The Company is obligated to pay, on a pro-rata basis, insurance premiums, real estate taxes and operating costs related to the premises. The lease expires in July 2022, with an option to renew on a month-to-month basis, with an increase in base rent as per the lease, for up to an additional year. The second lease is for office space in Lexington, Massachusetts, that expires August 2023, with an option to renew for a one-time, three-year extension. The initial annual base rent is $28.50 per square foot and will increase $1.00 per square foot at the end of each rent year.

In 2018, the Company received a lease incentive for the buildout of 420 Bedford Street in Lexington, MA. The Company was given an allowance for $165 on behalf of the lessor for construction of office space. Management recognizes this allowance as a lease incentive in its Right-of-Use asset and straight-lines the allowance throughout the term of the lease. As of March 31, 2022, the remaining rent incentive pertaining to the Lexington, MA lease totaled $54.

In January 2021, the Company signed a lease for 50,581 square feet of office and laboratory space at One Research Way in Princeton, New Jersey. The Company intends to complete the relocation of their headquarters from Cranbury, NJ to One Research Way in Princeton NJ in early 2022. That lease term extends through 2032, has a five-year extension option, and is intended to replace the Company’s two existing facilities and the space is expected to become the Company’s future headquarters. Payment under this lease will total $19,889 through May 2032. The Company received a lease incentive of $4,046 from the lessor for a buildout of laboratory, vivarium, and office space, to be reimbursed to the Company in 2021 and 2022. Management estimated the timing and amounts of reimbursements and included them as a reduction of lease payments when initially measuring the lease liability and right-of-use asset upon commencement. As of March 31, 2022, $786 of reimbursements were received.

The components of lease cost for the three months ended March 31, 2022, and 2021 are as follows, in thousands:

 

(in thousands)

 

Three Months

Ended

March 31,

2022

 

 

Three Months

Ended

March 31,

2021

 

Operating lease cost

 

$

511

 

 

$

157

 

Variable lease cost

 

 

197

 

 

 

95

 

Total lease cost

 

$

708

 

 

$

252

 

 

 

Amounts reported in the balance sheet for leases where the Company is the lessee as of March 31, 2022, and December 31, 2021 were as follows, in thousands:

 

Operating Leases:

 

March 31,

2022

 

 

December 31,

2021

 

Right-of-use assets, operating leases

 

$

9,736

 

 

$

10,060

 

 

 

 

 

 

 

 

 

 

Operating lease liabilities, current

 

$

258

 

 

$

403

 

Operating lease liabilities, non-current

 

 

11,480

 

 

 

10,790

 

Total operating lease liabilities

 

$

11,738

 

 

$

11,193

 

 

 

 

 

 

 

 

 

 

Weighted-average remaining lease term (years)

 

 

9.93

 

 

 

10.02

 

Weighted-average discount rate

 

 

5.75

%

 

 

5.75

%

 

Other information related to leases for the three months ended March 31, 2022, and 2021 is as follows, in thousands:

 

 

 

Three Months

Ended

March 31,

2022

 

 

Three Months

Ended

March 31,

2021

 

Net cash paid for amounts included in the measurement of lease liabilities

 

$

(358

)

 

$

174

 

Leased assets obtained in exchange for new operating lease liabilities

 

 

10,349

 

 

 

-

 

 

 

9


 

 

Future minimum lease payments, net of reimbursements, remaining as of March 31, 2022, under operating leases by fiscal year were as follows, in thousands:

 

Fiscal year

 

 

 

 

2021

 

$

(2,251

)

2022

 

 

1,833

 

2023

 

 

1,814

 

2024

 

 

1,869

 

2025

 

 

1,925

 

Thereafter

 

 

11,477

 

Total minimum lease payments

 

$

16,667

 

Less: Amounts representing imputed interest

 

 

(4,929

)

Present value of lease liabilities

 

$

11,738

 

 

Rent expense recorded during the three months ended March 31, 2022, and 2021 was $511 and $137, respectively.

 

The Company currently subleases the office space at 420 Bedford Street in Lexington, MA to another company. This sublease agreement expires in August, 2023. As of March 31, sublease income for the Company was $29 and $25 for the three months ended 2022 and 2021, respectively.

 

 

Contingencies

From time to time, the Company may have certain contingent liabilities that arise in the ordinary course of its business activities. The Company accrues a liability for such matters when future expenditures are probable and such expenditures can be reasonably estimated.

 

7. Stockholders’ Equity

The Company is authorized to issue up to 1,000,000,000 shares of common stock with a par value of $0.00001 per share and 5,000,000 shares of preferred stock with a par value of $0.00001 per share. At March 31, 2022 and December 31, 2021, there were 45,532,392 and 45,433,684 shares of common stock issued and outstanding, respectively.

Common stockholders are entitled to receive dividends if and when declared by the board of directors subject to the rights of any preferred stockholders.  As of March 31, 2022, no dividends on common stock had been declared by the Company.

8. Stock Plan

2020 Equity Incentive Plan

The 2020 Equity Incentive Plan (the “2020 Plan”) was approved by the board of directors on September 24, 2020. The 2020 Plan provides for the grant of incentive stock options, non-qualified stock options, stock appreciation rights, restricted stock units, restricted stock awards, unrestricted stock awards, cash-based awards and dividend equivalent rights to the Company’s officers, employees, directors, and consultants. The number of shares of common stock initially reserved for issuance under the 2020 Plan is 4,406,374, which shall be increased, upon approval by the board of directors, on January 1, 2021 and each January 1 thereafter, in an amount equal to the least of (i) 4,406,374 shares of common stock, (ii) five percent (5%) of the outstanding common stock on the immediately preceding December 31, or (iii) such number of common stock determined by the board of directors no later than the immediately preceding December 31.  For 2022, the board of directors exercised its discretion under clause (iii) to increase the number of shares of common stock reserved for issuance under the 2020 Plan by a lesser amount of 1,363,084 shares, effective as of January 1, 2022. As of March 31, 2022, there were 5,321,975 shares available for issuance under the 2020 Plan.

10


 

2020 Employee Stock Purchase Plan

The 2020 Employee Stock Purchase Plan (the “2020 ESPP”) was approved by the board of directors on September 24, 2020. A total of 400,572 shares of common stock were initially reserved for issuance under this plan, which shall be increased, upon approval by the board of directors, on January 1, 2021 and each January 1 thereafter, to the lesser of (i) 801,504 shares of common stock, (ii) 1% of the outstanding shares of common stock on the last day of the immediately preceding fiscal year, or (iii) an amount determined by the board of directors or any of its committees no later than the last day of the immediately preceding fiscal year.  For 2022, the board waived the increase to the shares reserved under the 2020 ESPP. As of March 31, 2022, 47,066 shares are issued or outstanding, and there were 801,464 shares available for issuance, under the 2020 ESPP.

Stock-Based Compensation

The following table summarizes option activity for the three month period ended March 31, 2022:

 

<

 

 

 

 

 

 

Options Outstanding

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted-

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted

 

 

Average

 

 

Aggregate

 

 

 

Shares

 

 

 

 

 

 

Average

 

 

Remaining

 

 

Intrinsic

 

 

 

Available

 

 

Number of

 

 

Exercise

 

 

Contractual Life

 

 

Value

 

 

 

for Grant

 

 

Options

 

 

Price

 

 

(in years)

 

 

(in 000s)