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, 2023

OR

 

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

 

For the transition period from to

Commission File Number: 001-39370

 

 

Nkarta, Inc.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware

47-4515206

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification No.)

6000 Shoreline Court, Suite 102

South San Francisco, CA

94080

(Address of principal executive offices)

(Zip Code)

 

(925) 407-1049

(Registrant’s telephone number, including area code)

 

Not applicable

(Former name, former address and former fiscal year, if changed since last report)

 

 

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, $0.0001 par value per share

 

NKTX

 

 

The Nasdaq Stock Market LLC

(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 8, 2023, the registrant had 48,934,928 shares of common stock, par value $0.0001 per share, outstanding.

 

 


Table of Contents

 

Page

PART I.

FINANCIAL INFORMATION

Item 1.

Financial Statements:

1

Condensed Balance Sheets as of March 31, 2023 and December 31, 2022 (unaudited)

1

Condensed Statements of Operations and Comprehensive Loss for the three months ended March 31, 2023 and 2022 (unaudited)

2

Condensed Statements of Stockholders’ Equity for the three months ended March 31, 2023 and 2022 (unaudited)

3

Condensed Statements of Cash Flows for the three months ended March 31, 2023 and 2022 (unaudited)

5

Notes to Unaudited Condensed Financial Statements

6

Item 2.

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

16

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

24

Item 4.

Controls and Procedures

24

PART II.

OTHER INFORMATION

 

Item 1.

Legal Proceedings

25

Item 1A.

Risk Factors

25

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

70

Item 3.

Defaults Upon Senior Securities

71

Item 4.

Mine Safety Disclosures

71

Item 5.

Other Information

71

Item 6.

Exhibits

72

Signatures

74

 

i


CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS


 

This Quarterly Report on Form 10-Q, and the information incorporated herein by reference, particularly in the sections captioned “Risk Factors” under Part II, Item 1A, and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” under Part I, Item 2, contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. 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, these statements are based on our management’s beliefs and assumptions and on information currently available to our management as of the date of this Quarterly Report on Form 10-Q. 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. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. You should read the sections titled “Risk Factor Summary” below and “Risk Factors” set forth in Part II, Item 1A of this Quarterly Report on Form 10-Q 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, which such factors may be updated or supplemented from time to time by subsequent reports we file with the Securities and Exchange Commission.

 

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.

 

ii


RISK FACTOR SUMMARY

 

Below is a summary of material factors that make an investment in our common stock speculative or risky. Importantly, this summary does not address all the risks and uncertainties that we face. Additional discussion of the risks and uncertainties summarized in this risk factor summary, as well as other risks and uncertainties that we face, can be found under Part II, Item 1A, “Risk Factors” in this Quarterly Report on Form 10-Q. The below summary is qualified in its entirety by the more complete discussion of such risks and uncertainties. You should consider carefully the risks and uncertainties described under Part II, Item 1A, “Risk Factors” in this Quarterly Report on Form 10-Q as part of your evaluation of an investment in our common stock.

 

We have a limited operating history and do not have any products approved for sale.
We have incurred significant losses since our inception and we expect to continue to incur significant losses for the foreseeable future.
We have never generated revenue from product sales and may never achieve or maintain profitability.
We will require additional capital, which, if available, may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our product candidates.
Our business depends upon the success of our CAR NK cell technology platform.
Utilizing CAR NK cells represents a novel approach to the treatment of cancer, and we must overcome significant challenges in order to develop, commercialize and manufacture our product candidates.
Clinical development involves a lengthy and expensive process with an uncertain outcome, and we may encounter substantial delays due to a variety of reasons outside our control.
Our business is highly dependent on the clinical success of our product candidates, and on the clinical success of NKX101 and NKX019 in particular, and we may fail to develop NKX101, NKX019 and/or our other product candidates successfully or be unable to obtain regulatory approval for them.
Enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be delayed, made more difficult or rendered impossible by multiple factors outside our control.
Our preclinical pipeline programs may experience delays or may never advance to clinical trials, which would adversely affect our ability to obtain regulatory approvals or commercialize these programs on a timely basis or at all.
The results of preclinical studies and early-stage clinical trials may not be predictive of future results. Interim, “topline” and preliminary data from our clinical trials may differ materially from the final data. Initial success in any clinical trials may not be indicative of results obtained when these trials are completed or in later stage trials.
If any of our product candidates, or any competing product candidates, demonstrate relevant, serious adverse events, we may be required to halt or delay further clinical development.
Our business and the business or operations of our research partners and other third parties with whom we conduct business have been and could continue to be adversely affected by the effects of health epidemics, including the COVID-19 pandemic, in regions where we or third parties on which we rely have business operations.
We have entered into a research collaboration with CRISPR Therapeutics regarding certain product candidates, and we may enter into additional collaborations with third parties to develop or commercialize other product candidates. Our prospects with respect to those product candidates will depend in significant part on the success of those collaborations, and we may not realize the benefits of such collaborations.
If we fail to compete effectively with academic institutions and other biopharmaceutical companies that develop similar or alternatives to cellular immunotherapy product candidates, our business will be materially adversely affected.
Our manufacturing process is novel and complex, and we may encounter difficulties in production, or difficulties with internal manufacturing, which would delay or prevent our ability to provide a sufficient supply of our product candidates for clinical trials or our products for patients, if approved.
We rely on third parties to manufacture certain of our product candidates, or certain materials for use in the production of our product candidates, which increases the risk that we will not have sufficient quantities of such product candidates or materials, or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.
We are reliant on a sole supplier for certain steps of our manufacturing process.

iii


Delays in commissioning and receiving regulatory approvals for our manufacturing facilities could delay our development plans and thereby limit our ability to develop our product candidates and generate revenues.
If our license agreement with National University of Singapore and St. Jude Children’s Research Hospital, Inc. is terminated, we could lose our rights to key components enabling our NK cell engineering platform.
If any patent protection we obtain is not sufficiently robust, our competitors could develop and commercialize products and technology similar or identical to ours.
If any of our product candidates are approved for marketing and commercialization and we have not developed or secured marketing, sales and distribution capabilities, either internally or from third parties, we will be unable to successfully commercialize such products and may not be able to generate product revenue.
Our product candidates, including NKX101 and NKX019, could be subject to regulatory limitations following approval, if and when such approval is granted.
The market price for our common stock may be volatile, which could contribute to the loss of all or part of your investment.
Concentration of ownership of our shares of common stock among our existing executive officers, directors and principal stockholders may prevent new investors from influencing significant corporate decisions.

 

 

 

 

 

 

iv


PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

NKARTA, INC.

CONDENSED BALANCE SHEETS

(Unaudited, in thousands)

 

 

 

March 31,
2023

 

 

December 31,
2022

 

Assets

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

Cash and cash equivalents

 

$

53,666

 

 

$

37,494

 

Short-term investments

 

 

269,675

 

 

 

314,649

 

Prepaid expenses and other current assets

 

 

8,847

 

 

 

8,545

 

Total current assets

 

 

332,188

 

 

 

360,688

 

Long-term investments

 

 

6,016

 

 

 

 

Restricted cash

 

 

2,743

 

 

 

2,743

 

Property and equipment, net

 

 

69,777

 

 

 

61,908

 

Operating lease right-of-use assets

 

 

45,575

 

 

 

45,749

 

Other long-term assets

 

 

1,870

 

 

 

1,850

 

Total assets

 

$

458,169

 

 

$

472,938

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

Accounts payable

 

$

5,411

 

 

$

1,761

 

Operating lease liabilities, current portion

 

 

5,752

 

 

 

4,249

 

Accrued and other current liabilities

 

 

14,818

 

 

 

16,036

 

Total current liabilities

 

 

25,981

 

 

 

22,046

 

Operating lease liabilities, net of current portion

 

 

85,542

 

 

 

78,685

 

Total liabilities

 

 

111,523

 

 

 

100,731

 

Commitments and contingencies (Note 7)

 

 

 

 

 

 

Stockholders’ equity

 

 

 

 

 

 

Common stock

 

 

5

 

 

 

5

 

Additional paid-in capital

 

 

695,563

 

 

 

690,814

 

Accumulated other comprehensive loss

 

 

(174

)

 

 

(679

)

Accumulated deficit

 

 

(348,748

)

 

 

(317,933

)

Total stockholders’ equity

 

 

346,646

 

 

 

372,207

 

Total liabilities and stockholders’ equity

 

$

458,169

 

 

$

472,938

 

 

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

1


NKARTA, INC.

CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

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

 

 

 

Three Months Ended
March 31,

 

 

 

2023

 

 

2022

 

Operating expenses:

 

 

 

 

 

 

Research and development

 

$

26,135

 

 

$

19,568

 

General and administrative

 

 

8,178

 

 

 

6,530

 

Total operating expenses

 

 

34,313

 

 

 

26,098

 

Loss from operations

 

 

(34,313

)

 

 

(26,098

)

Other income (expense), net:

 

 

 

 

 

 

Interest income

 

 

3,465

 

 

 

112

 

Other income (expense), net

 

 

33

 

 

 

(1

)

Total other income, net

 

 

3,498

 

 

 

111

 

Net loss

 

$

(30,815

)

 

$

(25,987

)

Other comprehensive loss:

 

 

 

 

 

 

Net unrealized gain (loss) on investments

 

 

505

 

 

 

(456

)

Comprehensive loss

 

$

(30,310

)

 

$

(26,443

)

Net loss per share, basic and diluted

 

$

(0.63

)

 

$

(0.79

)

Weighted average shares used to compute net loss
   per share, basic and diluted

 

 

48,921,326

 

 

 

32,992,582

 

 

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

2


NKARTA, INC.

CONDENSED STATEMENTS OF STOCKHOLDERS’ EQUITY

(Unaudited, in thousands, except share data)

 

 

 

Common Stock

 

 

Additional
Paid-in

 

 

Accumulated
Other
Comprehensive

 

 

Accumulated

 

 

Total
Stockholders'

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Loss

 

 

Deficit

 

 

Equity

 

Balance, December 31, 2022

 

 

48,877,806

 

 

$

5

 

 

$

690,814

 

 

$

(679

)

 

$

(317,933

)

 

$

372,207

 

Vesting of shares of common
   stock subject to repurchase

 

 

395

 

 

 

 

 

 

2

 

 

 

 

 

 

 

 

 

2

 

Issuance of common stock
   upon exercise of stock
   options

 

 

253

 

 

 

 

 

 

1

 

 

 

 

 

 

 

 

 

1

 

Issuance of common stock
   upon vesting of restricted stock units

 

 

50,469

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Share-based compensation
   expense

 

 

 

 

 

 

 

 

4,746

 

 

 

 

 

 

 

 

 

4,746

 

Unrealized gain on
   investments

 

 

 

 

 

 

 

 

 

 

 

505

 

 

 

 

 

 

505

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(30,815

)

 

 

(30,815

)

Balance, March 31, 2023

 

 

48,928,923

 

 

$

5

 

 

$

695,563

 

 

$

(174

)

 

$

(348,748

)

 

$

346,646

 

 

3


NKARTA, INC.

CONDENSED STATEMENTS OF STOCKHOLDERS’ EQUITY

(Unaudited, in thousands, except share data)

 

 

 

Common Stock

 

 

Additional
Paid-in

 

 

Accumulated
Other
Comprehensive

 

 

Accumulated

 

 

Total
Stockholders'

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Loss

 

 

Deficit

 

 

Equity

 

Balance, December 31, 2021

 

 

32,971,107

 

 

$

3

 

 

$

455,210

 

 

$

(150

)

 

$

(204,096

)

 

$

250,967

 

Vesting of shares of common
   stock subject to repurchase

 

 

10,924

 

 

 

 

 

 

6

 

 

 

 

 

 

 

 

 

6

 

Issuance of common stock
   upon exercise of stock
   options

 

 

21,067

 

 

 

 

 

 

79

 

 

 

 

 

 

 

 

 

79

 

Share-based compensation
   expense

 

 

 

 

 

 

 

 

4,097

 

 

 

 

 

 

 

 

 

4,097

 

Unrealized loss on
   short-term investments

 

 

 

 

 

 

 

 

 

 

 

(456

)

 

 

 

 

 

(456

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(25,987

)

 

 

(25,987

)

Balance, March 31, 2022

 

 

33,003,098

 

 

$

3

 

 

$

459,392

 

 

$

(606

)

 

$

(230,083

)

 

$

228,706

 

 

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

4


NKARTA, INC.

CONDENSED STATEMENT OF CASH FLOWS

(Unaudited, in thousands)

 

 

 

Three Months Ended
March 31,

 

 

 

2023

 

 

2022

 

Cash flows from operating activities:

 

 

 

 

 

 

Net loss

 

$

(30,815

)

 

$

(25,987

)

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

 

 

 

 

 

 

Share-based compensation expense

 

 

4,746

 

 

 

4,097

 

Depreciation and amortization

 

 

797

 

 

 

610

 

Accretion and amortization of premiums and discounts on investments, net

 

 

(2,253

)

 

 

727

 

Realized gain on investments

 

 

(34

)

 

 

 

Non-cash lease expense

 

 

545

 

 

 

1,380

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

Prepaid expenses and other assets

 

 

(406

)

 

 

1,460

 

Operating lease liabilities

 

 

7,992

 

 

 

1,614

 

Accounts payable and accrued and other liabilities

 

 

(1,330

)

 

 

(2,159

)

Net cash used in operating activities

 

 

(20,758

)

 

 

(18,258

)

Cash flows from investing activities:

 

 

 

 

 

 

Purchases of property and equipment

 

 

(4,823

)

 

 

(1,770

)

Purchases of investments

 

 

(84,288

)

 

 

(28,472

)

Maturities of investments

 

 

126,040

 

 

 

29,216

 

Net cash provided by (used in) investing activities

 

 

36,929

 

 

 

(1,026

)

Cash flows from financing activities:

 

 

 

 

 

 

Proceeds from stock option exercises

 

 

1

 

 

 

79

 

Net cash provided by financing activities

 

 

1

 

 

 

79

 

Net increase (decrease) in cash and cash equivalents

 

 

16,172

 

 

 

(19,205

)

Cash, cash equivalents, and restricted cash beginning of period

 

 

40,237

 

 

 

62,914

 

Cash, cash equivalents, and restricted cash end of period

 

$

56,409

 

 

$

43,709

 

Reconciliation of cash, cash equivalents and restricted cash to the balance sheet:

 

 

 

 

 

 

Cash and cash equivalents

 

$

53,666

 

 

$

41,611

 

Restricted cash

 

 

2,743

 

 

 

2,098

 

Total cash, cash equivalents and restricted cash

 

$

56,409

 

 

$

43,709

 

Supplemental disclosures of non-cash investing activities:

 

 

 

 

 

 

Acquisitions of property and equipment in accounts payable

 

$

3,761

 

 

$

37

 

 

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

5


NKARTA, INC.

NOTES TO FINANCIAL STATEMENTS

(Unaudited)

 

1. Organization and Description of Business

Description of the Business

Nkarta, Inc. ("Nkarta" or the "Company") was incorporated in the State of Delaware in July 2015. The Company is a biopharmaceutical company developing engineered natural killer ("NK") cells to treat cancer. The Company is focused on leveraging the natural potent power of NK cells to identify and kill abnormal cells and recruit adaptive immune effectors to generate responses that are specific and durable. Nkarta is combining its NK expansion platform technology with proprietary cell engineering technologies to generate an abundant supply of NK cells, engineer enhanced NK cell recognition of tumor targets, and improve persistence for sustained activity in the body for the treatment of cancer. Nkarta’s goal is to develop off-the-shelf NK cell therapy product candidates to improve outcomes for patients. The Company’s operations are based in South San Francisco, California, and it operates in one segment.

Liquidity and Management Plans

The accompanying unaudited condensed financial statements have been prepared assuming that the Company will continue as a going concern. However, since inception, the Company has devoted substantially all of its efforts to organizing and staffing, business planning, raising capital, conducting preclinical studies and initiating clinical studies, and has not realized substantial revenues from its planned principal operations. In addition, the Company has a limited operating history, has incurred operating losses since inception and expects that it will continue to incur net losses into the foreseeable future as it continues its research and development activities. As of March 31, 2023, the Company had an accumulated deficit of $348.7 million and cash, cash equivalents, restricted cash and investments of $332.1 million.

Management plans to continue to incur substantial costs in order to conduct research and development activities and additional capital will be needed to undertake these activities. The Company intends to raise such capital through debt or equity financings or other arrangements to fund operations. Management believes that the Company’s current cash, cash equivalents, restricted cash and investments will provide sufficient funds to enable the Company to meet its obligations for at least twelve months from the filing date of this report.

On March 17, 2023, the Company filed a Registration Statement on Form S-3, as amended by the Form S-3/A filed on April 24, 2023 (the "Shelf Registration Statement"), covering the offer and sale from time to time, pursuant to Rule 415 of the Securities Act of 1933, as amended (the "Securities Act"), of up to $350.0 million in aggregate offering price of shares of the Company’s common stock, shares of the Company’s preferred stock, debt securities, warrants, rights and/or units, including up to $120.0 million in aggregate offering price of shares of the Company’s common stock, shares of the Company’s preferred stock, debt securities, warrants, rights and/or units registered on the Company’s Registration Statement on Form S-3 declared effective by the Securities and Exchange Commission (the "SEC") on September 2, 2021 (the "Prior Registration Statement") that have not yet been sold. The Shelf Registration Statement was declared effective by the SEC on May 5, 2023.

On August 12, 2021, the Company entered into a sales agreement with Cowen and Company, LLC, a sales agent, to provide for the offering, issuance and sale of up to an aggregate of $150.0 million of the Company’s common stock through an “at-the-market” equity offering program (the "ATM Offering Program") pursuant to the Prior Registration Statement and subject to the limitations thereof. For the three months ended March 31, 2023, no sales of the Company’s common stock were made pursuant to the ATM Offering Program.

2. Basis of Presentation and Significant Accounting Policies

Basis of Presentation

The accompanying unaudited condensed financial statements as of March 31, 2023 and for the three-months ended March 31, 2023 and 2022 have been prepared in accordance with U.S. generally accepted accounting principle ("U.S. GAAP") for interim financial information and pursuant to Article 10 of Regulation S-X of the Securities Act, as amended. Accordingly, they do not include all of the information and notes required by U.S. GAAP for complete financial statements. These unaudited condensed financial statements include only normal and recurring adjustments that the Company believes are necessary to fairly state the Company’s financial position and the results of its operations and cash flows for the periods presented.

6


The results for the three months ended March 31, 2023 are not necessarily indicative of the results expected for the full year or any subsequent interim period. The condensed balance sheet at December 31, 2022 has been derived from the audited financial statements at that date but does not include all disclosures required by U.S. GAAP for complete financial statements. Because all of the disclosures required by U.S. GAAP for complete financial statements are not included herein, these unaudited condensed financial statements and the notes accompanying them should be read in conjunction with the Company’s audited financial statements for the year ended December 31, 2022, contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 filed by the Company with the SEC on March 16, 2023.

COVID-19 Pandemic

The COVID-19 pandemic has caused disruptions in the global economy and has affected and may affect the Company’s business and operations in the future. In response to the pandemic, the Coronavirus Aid, Relief and Economic Security Act (the "CARES Act") was signed into law on March 27, 2020. The CARES Act, among other things, includes tax provisions relating to refundable payroll tax credits, deferment of employer’s social security payments, net operating loss utilization and carryback periods, modifications to the net interest deduction limitations and technical corrections to tax depreciation methods for qualified improvement property. The CARES Act had no impact on the Company’s income tax provision for the year ended December 31, 2022 or the three months ended March 31, 2023. The Company continues to evaluate the impact of the CARES Act on its financial position, results of operations and cash flows.

Use of Estimates

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the Company’s financial statements and accompanying notes. On an ongoing basis, management evaluates its estimates, including those related to preclinical studies, fair value of assets and liabilities, leases, share-based compensation and income taxes. Management bases its estimates on historical experience, knowledge of current events and actions it may undertake in the future that management believes to be reasonable under the circumstances. Actual results may differ from these estimates and assumptions.

Net Loss Per Share

Basic net loss per share is calculated by dividing the net loss by the weighted-average number of common shares outstanding for the period, without consideration of potential dilutive securities. Diluted net loss per share is computed by dividing the net loss by the sum of the weighted average number of common shares plus the potential dilutive effects of potential dilutive securities outstanding during the period. Potential dilutive securities are excluded from diluted earnings or loss per share if the effect of such inclusion is antidilutive. The Company’s potentially dilutive securities, which include convertible preferred stock prior to the conversion of such shares to common stock, unvested common stock, and outstanding stock options under the Company’s equity incentive plans, have been excluded from the computation of diluted net loss per share as they would be anti-dilutive to the net loss per share. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding due to the Company’s net loss position.

7


3. Net Loss Per Share

The following tables summarize the computation of the basic and diluted net loss per share (in thousands except share and per share data):

 

 

 

Three Months Ended
March 31,

 

 

 

2023

 

 

2022

 

Numerator:

 

 

 

 

 

 

Net loss

 

$

(30,815

)

 

$

(25,987

)

Denominator:

 

 

 

 

 

 

Weighted average common shares outstanding

 

 

48,921,535

 

 

 

33,000,238

 

Less: weighted average unvested common stock
   issued upon early exercise of common stock
   options

 

 

(209

)

 

 

(7,656

)

Weighted average shares used to compute net loss
   per share, basic and diluted

 

 

48,921,326

 

 

 

32,992,582

 

Net loss per share, basic and diluted

 

$

(0.63

)

 

$

(0.79

)

 

The following table summarizes the outstanding potentially dilutive securities that have been excluded in the calculation of diluted net loss per share because their inclusion would be anti-dilutive:

 

 

 

As of March 31,

 

 

 

2023

 

 

2022

 

Common stock options

 

 

6,820,096

 

 

 

5,070,367

 

Restricted stock units

 

 

799,930

 

 

 

229,418

 

Unvested common stock upon early exercise of common stock
   options

 

 

113

 

 

 

5,257

 

 

 

7,620,139

 

 

 

5,305,042

 

 

4. Fair Value of Financial Instruments

The following tables summarize the fair value of the Company’s financial instruments (in thousands):

 

 

 

 

 

 

Fair Value Measurements Using

 

 

 

March 31,
2023

 

 

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

 

 

Significant
Other
Observable
Inputs
(Level 2)

 

 

Significant
Unobservable
Inputs
(Level 3)

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

Cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

52,666

 

 

$

52,666

 

 

$

 

 

$

 

Short-term investments:

 

 

 

 

 

 

 

 

 

 

 

 

Corporate debt securities

 

$

50,351

 

 

$

 

 

$

50,351

 

 

$

 

Commercial paper

 

 

20,298

 

 

 

 

 

 

20,298

 

 

 

 

U.S. Government securities

 

 

199,026

 

 

 

 

 

 

199,026

 

 

 

 

Total short-term investments

 

 

269,675

 

 

 

 

 

 

269,675

 

 

 

 

Long-term investments:

 

 

 

 

 

 

 

 

 

 

 

 

U.S. Government securities

 

$

6,016

 

 

$

 

 

$

6,016

 

 

$

 

Total

 

$

328,357

 

 

$

52,666

 

 

$

275,691

 

 

$

 

 

8


 

 

 

 

 

Fair Value Measurements Using

 

 

 

December 31,
2022

 

 

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

 

 

Significant
Other
Observable
Inputs
(Level 2)

 

 

Significant
Unobservable
Inputs
(Level 3)

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

Cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

36,494

 

 

$

36,494

 

 

$

 

 

$

 

Short-term investments:

 

 

 

 

 

 

 

 

 

 

 

 

Corporate debt securities

 

$

88,681

 

 

$

 

 

$

88,681

 

 

$

 

Commercial paper

 

 

65,409

 

 

 

 

 

 

65,409

 

 

 

 

Government securities

 

 

160,559

 

 

 

 

 

 

160,559

 

 

 

 

Total short-term investments

 

 

314,649

 

 

 

 

 

 

314,649

 

 

 

 

Total

 

$

351,143

 

 

$

36,494

 

 

$

314,649

 

 

$

 

Cash Equivalents and Investments

Financial assets measured at fair value on a recurring basis consist of the Company’s cash equivalents and short-term and long-term investments. Cash equivalents consisted of money market funds and short-term and long-term investments consisted of commercial paper, government securities and corporate bonds. The Company obtains pricing information from its investment manager and generally determines the fair value of investment securities using standard observable inputs, including reported trades, broker/dealer quotes, and bids and/or offers.

Investments are classified as Level 1 within the fair value hierarchy if their quoted prices are available in active markets for identical securities. Investments in money market funds of $52.7 million and $36.5 million as of March 31, 2023 and December 31, 2022, respectively, were classified as Level 1 instruments and were included in cash and cash equivalents.

Investments in marketable securities are valued using Level 2 inputs. Level 2 securities are initially valued at the transaction price and subsequently valued and reported upon utilizing inputs other than quoted prices that are observable either directly or indirectly, such as quotes from third-party pricing vendors. Fair values determined by Level 2 inputs, which utilize data points that are observable such as quoted prices, interest rates and yield curves, require the exercise of judgment and use of estimates, that if changed, could significantly affect the Company’s financial position and results of operations. The marketable securities of $275.7 million and $314.6 million as of March 31, 2023 and December 31, 2022, respectively, were classified as Level 2 instruments. As of March 31, 2023, marketable securities of $269.7 million were included in short-term investments and marketable securities of $6.0 million were included in long-term investments. As of December 31, 2022, marketable securities of $314.6 million were included in short-term investments. Accrued interest receivable related to investments was $0.6 million and $0.8 million as of March 31, 2023 and December 31, 2022, respectively, and included as part of prepaid expenses and other current assets in the condensed balance sheets.

The following tables summarize the Company’s investments accounted for as available-for-sale securities as of March 31, 2023 and December 31, 2022 (in thousands):