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 September 30, 2023

OR

 

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

 

For the transition period from to

Commission File Number: 001-39527

 

 

PRELUDE THERAPEUTICS INCORPORATED

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware

81-1384762

(State or other jurisdiction of

incorporation or organization)

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

200 Powder Mill Road

Wilmington, Delaware

19803

(Address of principal executive offices)

(Zip Code)

 

Registrant’s telephone number, including area code: (302) 467-1280

 

 

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

 

PRLD

 

The Nasdaq Stock Market LLC

 

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

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

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

 

Large accelerated filer

Accelerated filer

 

 

 

 

Non-accelerated filer

Smaller reporting company

 

 

 

 

 

 

 

 

 

 

 

Emerging growth company

 

 

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

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

As of October 27, 2023, the registrant had 54,825,982 shares of voting and non-voting common stock, $0.0001 par value per share, outstanding.

 


 

Table of Contents

 

Page

PART I.

FINANCIAL INFORMATION

Item 1.

Financial Statements

1

Balance Sheets (Unaudited)

1

Statements of Operations and Comprehensive Loss (Unaudited)

2

Statements of Changes in Stockholders’ Equity (Unaudited)

3

Statements of Cash Flows (Unaudited)

5

Notes to Unaudited Interim 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, Use of Proceeds, and Issuer Purchases of Equity Securities

26

Item 3.

Defaults Upon Senior Securities

26

Item 4.

Mine Safety Disclosures

26

Item 5.

Other Information

26

Item 6.

Exhibits

27

Signatures

28

 

i


 

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

PRELUDE THERAPEUTICS INCORPORATED

BALANCE SHEETS

(UNAUDITED)

 

(in thousands, except share data)

 

September 30,
2023

 

 

December 31,
2022

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

15,896

 

 

$

30,605

 

Marketable securities

 

 

214,610

 

 

 

171,123

 

Prepaid expenses and other current assets

 

 

4,410

 

 

 

2,652

 

Total current assets

 

 

234,916

 

 

 

204,380

 

Restricted cash

 

 

4,044

 

 

 

4,044

 

Property and equipment, net

 

 

6,618

 

 

 

4,908

 

Right-of-use asset

 

 

464

 

 

 

1,792

 

Prepaid expenses and other non-current assets

 

 

12,469

 

 

 

5,376

 

Total assets

 

$

258,511

 

 

$

220,500

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

5,170

 

 

$

6,777

 

Accrued expenses and other current liabilities

 

 

11,248

 

 

 

13,093

 

Operating lease liability

 

 

475

 

 

 

1,832

 

Total current liabilities

 

 

16,893

 

 

 

21,702

 

Other liabilities

 

 

3,361

 

 

 

3,361

 

Total liabilities

 

 

20,254

 

 

 

25,063

 

Commitments (Note 8)

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

Voting common stock, $0.0001 par value: 487,149,741 shares authorized; 41,965,472 and 36,496,994 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively

 

 

4

 

 

 

4

 

Non-voting common stock, $0.0001 par value: 12,850,259 shares authorized; 12,850,259 and 11,402,037 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively

 

 

1

 

 

 

1

 

Additional paid-in capital

 

 

662,172

 

 

 

531,682

 

Accumulated other comprehensive loss

 

 

(605

)

 

 

(1,692

)

Accumulated deficit

 

 

(423,315

)

 

 

(334,558

)

Total stockholders’ equity

 

 

238,257

 

 

 

195,437

 

Total liabilities and stockholders’ equity

 

$

258,511

 

 

$

220,500

 

 

See accompanying notes to unaudited interim financial statements.

1


 

PRELUDE THERAPEUTICS INCORPORATED

STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(UNAUDITED)

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

(in thousands, except share and per share data)

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

26,261

 

 

$

22,889

 

 

$

73,061

 

 

$

67,020

 

General and administrative

 

 

7,124

 

 

 

7,517

 

 

 

21,837

 

 

 

23,135

 

Total operating expenses

 

 

33,385

 

 

 

30,406

 

 

 

94,898

 

 

 

90,155

 

Loss from operations

 

 

(33,385

)

 

 

(30,406

)

 

 

(94,898

)

 

 

(90,155

)

Other income, net

 

 

2,777

 

 

 

448

 

 

 

6,141

 

 

 

3,358

 

Net loss

 

$

(30,608

)

 

$

(29,958

)

 

$

(88,757

)

 

$

(86,797

)

Per share information:

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share of common stock, basic and diluted

 

$

(0.45

)

 

$

(0.63

)

 

$

(1.55

)

 

$

(1.84

)

Weighted average common shares outstanding, basic
   and diluted

 

 

67,639,993

 

 

 

47,449,811

 

 

 

57,278,795

 

 

 

47,265,712

 

Comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(30,608

)

 

$

(29,958

)

 

$

(88,757

)

 

$

(86,797

)

Unrealized (loss) gain on marketable securities, net of tax

 

 

106

 

 

 

(69

)

 

 

1,087

 

 

 

(1,652

)

Comprehensive loss

 

$

(30,502

)

 

$

(30,027

)

 

$

(87,670

)

 

$

(88,449

)

 

See accompanying notes to unaudited interim financial statements.

2


 

PRELUDE THERAPEUTICS INCORPORATED

STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY

(UNAUDITED)

 

 

 

 

 

 

Voting common stock

 

 

Non-voting common
stock

 

 

Additional paid-in

 

 

Accumulated other comprehensive

 

 

Accumulated

 

 

 

 

(in thousands, except shares)

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

capital

 

 

loss

 

 

deficit

 

 

Total

 

Balance at January 1, 2023

 

 

36,496,994

 

 

$

4

 

 

 

11,402,037

 

 

$

1

 

 

$

531,682

 

 

$

(1,692

)

 

$

(334,558

)

 

$

195,437

 

Issuance of common stock upon exercise of stock options & vesting of RSUs

 

 

17,224

 

 

 

 

 

 

 

 

 

 

 

 

28

 

 

 

 

 

 

 

 

 

28

 

Unrealized gain on marketable securities, net of tax

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,294

 

 

 

 

 

 

1,294

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

6,256

 

 

 

 

 

 

 

 

 

6,256

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(27,718

)

 

 

(27,718

)

Balance at March 31, 2023

 

 

36,514,218

 

 

$

4

 

 

 

11,402,037

 

 

$

1

 

 

$

537,966

 

 

$

(398

)

 

$

(362,276

)

 

$

175,297

 

Issuance of common stock and prefunded warrants, net of issuance costs of $2.6 million

 

 

5,312,978

 

 

 

 

 

 

1,448,222

 

 

 

 

 

 

110,423

 

 

 

 

 

 

 

 

 

110,423

 

Issuance of common stock upon exercise of stock options & vesting of RSU's

 

 

40,461

 

 

 

 

 

 

 

 

 

 

 

 

3

 

 

 

 

 

 

 

 

 

3

 

Issuance of common stock under ESPP

 

 

90,799

 

 

 

 

 

 

 

 

 

 

 

 

348

 

 

 

 

 

 

 

 

 

348

 

Unrealized loss on marketable securities, net of tax

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(313

)

 

 

 

 

 

(313

)

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

6,733

 

 

 

 

 

 

 

 

 

6,733

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(30,431

)

 

 

(30,431

)

Balance at June 30, 2023

 

 

41,958,456

 

 

$

4

 

 

 

12,850,259

 

 

$

1

 

 

$

655,473

 

 

$

(711

)

 

$

(392,707

)

 

$

262,060

 

Issuance of common stock upon vesting of RSU's, net of 3,609 shares withheld for employee taxes

 

 

7,016

 

 

 

 

 

 

 

 

 

 

 

 

(16

)

 

 

 

 

 

 

 

 

(16

)

Unrealized gain (loss) on marketable securities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

106

 

 

 

 

 

 

106

 

Stock-based compensation expense, net of forfeitures of restricted stock awards

 

 

 

 

 

 

 

 

 

 

 

 

 

 

6,715

 

 

 

 

 

 

 

 

 

6,715

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(30,608

)

 

 

(30,608

)

Balance at September 30, 2023

 

 

41,965,472

 

 

$

4

 

 

 

12,850,259

 

 

$

1

 

 

$

662,172

 

 

$

(605

)

 

$

(423,315

)

 

$

238,257

 

See accompanying notes to unaudited interim financial statements.

 

3


 

PRELUDE THERAPEUTICS INCORPORATED

STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (CONTINUED)

(UNAUDITED)

 

 

 

 

 

 

Voting common stock

 

 

Non-voting common stock

 

 

Additional paid-in

 

 

Accumulated other comprehensive

 

 

Accumulated

 

 

 

 

(in thousands, except shares)

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

capital

 

 

loss

 

 

deficit

 

 

Total

 

Balance at January 1, 2022

 

 

36,200,299

 

 

$

4

 

 

 

11,402,037

 

 

$

1

 

 

$

505,723

 

 

$

(711

)

 

$

(219,120

)

 

$

285,897

 

Issuance of common stock upon exercise of stock options

 

 

93,032

 

 

 

 

 

 

 

 

 

 

 

 

153

 

 

 

 

 

 

 

 

 

153

 

Unrealized loss on marketable securities, net of tax

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(1,602

)

 

 

 

 

 

(1,602

)

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

6,829

 

 

 

 

 

 

 

 

 

6,829

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(29,465

)

 

 

(29,465

)

Balance at March 31, 2022

 

 

36,293,331

 

 

$

4

 

 

 

11,402,037

 

 

$

1

 

 

$

512,705

 

 

$

(2,313

)

 

$

(248,585

)

 

$

261,812

 

Issuance of common stock upon exercise of stock options

 

 

31,253

 

 

 

 

 

 

 

 

 

 

 

 

59

 

 

 

 

 

 

 

 

 

59

 

Issuance of common stock under ESPP

 

 

68,080

 

 

 

 

 

 

 

 

 

 

 

 

300

 

 

 

 

 

 

 

 

 

300

 

Unrealized gain on marketable securities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

19

 

 

 

 

 

 

19

 

Stock-based compensation expense, net of forfeitures of restricted stock awards

 

 

(23,416

)

 

 

 

 

 

 

 

 

 

 

 

6,028

 

 

 

 

 

 

 

 

 

6,028

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(27,374

)

 

 

(27,374

)

Balance at June 30, 2022

 

 

36,369,248

 

 

$

4

 

 

 

11,402,037

 

 

$

1

 

 

$

519,092

 

 

$

(2,294

)

 

$

(275,959

)

 

$

240,844

 

Issuance of common stock upon exercise of stock options

 

 

75,528

 

 

 

 

 

 

 

 

 

 

 

 

148

 

 

 

 

 

 

 

 

 

148

 

Unrealized gain(loss) on marketable securities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(69

)

 

 

 

 

 

(69

)

Stock-based compensation expense, net of forfeitures of restricted stock awards

 

 

 

 

 

 

 

 

 

 

 

 

 

 

6,442

 

 

 

 

 

 

 

 

 

6,442

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(29,958

)

 

 

(29,958

)

Balance at September 30, 2022

 

 

36,444,776

 

 

$

4

 

 

 

11,402,037

 

 

$

1

 

 

$

525,682

 

 

$

(2,363

)

 

$

(305,917

)

 

$

217,407

 

See accompanying notes to unaudited interim financial statements.

4


 

PRELUDE THERAPEUTICS INCORPORATED

STATEMENTS OF CASH FLOWS

(UNAUDITED)

 

 

 

Nine months ended September 30,

 

(in thousands)

 

2023

 

 

2022

 

Cash flows used in operating activities:

 

 

 

 

 

 

Net loss

 

$

(88,757

)

 

$

(86,797

)

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

 

 

 

 

 

 

Depreciation and amortization

 

 

838

 

 

 

962

 

Noncash lease expense

 

 

1,328

 

 

 

1,281

 

Stock-based compensation

 

 

19,704

 

 

 

19,299

 

Amortization of premium and discount on marketable securities, net

 

 

(2,402

)

 

 

2,770

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

Prepaid expenses and other current assets

 

 

(2,053

)

 

 

(3,591

)

Accounts payable

 

 

(1,805

)

 

 

2,893

 

Accrued expenses and other liabilities

 

 

(1,873

)

 

 

3,661

 

Long-term prepaid expenses and other long-term assets

 

 

(7,108

)

 

 

 

Operating lease liabilities

 

 

(1,357

)

 

 

(1,280

)

Net cash used in operating activities

 

 

(83,485

)

 

 

(60,802

)

Cash flows (used in) provided by investing activities:

 

 

 

 

 

 

Purchases of marketable securities

 

 

(162,248

)

 

 

(85,972

)

Proceeds from maturities of marketable securities

 

 

122,250

 

 

 

168,934

 

Purchases of property and equipment

 

 

(2,384

)

 

 

(2,626

)

Net cash (used in) provided by investing activities

 

 

(42,382

)

 

 

80,336

 

Cash flows provided by financing activities:

 

 

 

 

 

 

Proceeds from issuance of common stock and pre-funded warrants, net of offering costs

 

 

110,795

 

 

 

 

Proceeds from the issuance of common stock under ESPP

 

 

348

 

 

 

300

 

Proceeds from the issuance of common stock in connection with the exercise of stock options

 

 

31

 

 

 

360

 

Payment of withholding taxes related to stock-based compensation to employees

 

 

(16

)

 

 

 

Net cash provided by financing activities

 

 

111,158

 

 

 

660

 

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

 

 

(14,709

)

 

 

20,194

 

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

 

 

34,649

 

 

 

35,872

 

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

 

$

19,940

 

 

$

56,066

 

Supplemental disclosures:

 

 

 

 

 

 

Operating lease right-of-use assets obtained in exchange for operating lease liabilities

 

$