10-Q
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

FORM 10-Q

 

(Mark One)

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

For the quarterly period ended June 30, 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: 001-41365

 

HILLEVAX, INC.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware

85-0545060

(State or other jurisdiction of

incorporation or organization)

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

75 State Street, Suite 100 - #9995, Boston, Massachusetts

02109

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (617) 213-5054

 

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

 

HLVX

 

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 August 8, 2023, the registrant had 39,216,931 shares of common stock, $0.0001 par value per share, outstanding.

 

 


 

Table of Contents

 

 

 

Page

PART I

FINANCIAL INFORMATION

1

 

 

 

Item 1.

Financial Statements (Unaudited)

1

 

Condensed Consolidated Balance Sheets

1

 

Condensed Consolidated Statements of Operations and Comprehensive Loss

2

 

Condensed Consolidated Statements of Stockholders' Equity (Deficit)

3

 

Condensed Consolidated Statements of Cash Flows

5

 

Notes to Condensed Consolidated Financial Statements

6

Item 2.

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

23

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

33

Item 4.

Controls and Procedures

33

 

 

 

PART II

OTHER INFORMATION

33

 

 

 

Item 1.

Legal Proceedings

33

Item 1A.

Risk Factors

33

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

34

Item 3.

Defaults Upon Senior Securities

34

Item 4.

Mine Safety Disclosures

34

Item 5.

Other Information

34

Item 6.

Exhibits

35

Signatures

36

 

 

 


 

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

HilleVax, Inc.

Condensed Consolidated Balance Sheets

(in thousands, except share and par value data)

(unaudited)

 

June 30,

 

 

December 31,

 

 

 

2023

 

 

2022

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

158,375

 

 

$

279,401

 

Marketable securities

 

 

85,675

 

 

 

 

Prepaid expenses and other current assets (includes related party amounts of $48 and $0, respectively)

 

 

8,989

 

 

 

11,212

 

Total current assets

 

 

253,039

 

 

 

290,613

 

Property and equipment, net

 

 

13,143

 

 

 

5,586

 

Operating lease right-of-use assets

 

 

18,686

 

 

 

19,359

 

Restricted cash

 

 

1,631

 

 

 

1,631

 

Other assets

 

 

23

 

 

 

22

 

Total assets

 

$

286,522

 

 

$

317,211

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable (includes related party amounts of $0 and $141,
   respectively)

 

$

151

 

 

$

4,744

 

Accrued expenses (includes related party amounts of $12 and $140,
   respectively)

 

 

17,648

 

 

 

8,210

 

Accrued interest

 

 

102

 

 

 

55

 

Current portion of operating lease liability

 

 

437

 

 

 

37

 

Total current liabilities

 

 

18,338

 

 

 

13,046

 

Operating lease liability, net of current portion

 

 

23,664

 

 

 

21,569

 

Long-term debt, net of debt discount

 

 

24,835

 

 

 

14,792

 

Other long-term liabilities

 

 

922

 

 

 

575

 

Total liabilities

 

 

67,759

 

 

 

49,982

 

Commitments and contingencies (Note 8)

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

Preferred stock, $0.0001 par value; authorized shares— 50,000,000 at June 30, 2023
and December 31, 2022;
no shares issued and outstanding at June 30, 2023 and
December 31, 2022

 

 

 

 

 

 

Common stock, $0.0001 par value; authorized shares— 500,000,000 at June 30, 2023
and December 31, 2022; issued shares—
39,216,931 and 39,240,746 at
June 30, 2023 and December 31, 2022, respectively; outstanding shares—
38,049,186 and 37,656,037 at June 30, 2023 and December 31, 2022, respectively

 

 

4

 

 

 

4

 

Additional paid-in capital

 

 

538,865

 

 

 

532,499

 

Accumulated other comprehensive loss

 

 

(322

)

 

 

(281

)

Accumulated deficit

 

 

(319,784

)

 

 

(264,993

)

Total stockholders’ equity

 

 

218,763

 

 

 

267,229

 

Total liabilities and stockholders’ equity

 

$

286,522

 

 

$

317,211

 

 

See accompanying notes.

1


 

HilleVax, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(in thousands, except share and per share data)

(unaudited)

 

 

Three Months Ended
June 30,

 

 

Six Months Ended
June 30,

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development (includes related party
   amounts of $
29, $172, $197, and $1,594, respectively)

 

$

22,953

 

 

$

8,826

 

 

$

46,117

 

 

$

15,037

 

In-process research and development - related party

 

 

 

 

 

 

 

 

 

 

 

2,500

 

General and administrative (includes related party
   amounts of $
3, $8, $6, and $34, respectively)

 

 

7,231

 

 

 

3,982

 

 

 

13,026

 

 

 

6,585

 

Total operating expenses

 

 

30,184

 

 

 

12,808

 

 

 

59,143

 

 

 

24,122

 

Loss from operations

 

 

(30,184

)

 

 

(12,808

)

 

 

(59,143

)

 

 

(24,122

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

2,453

 

 

 

334

 

 

 

5,027

 

 

 

340

 

Interest expense (includes related party amounts
   of $
0, $188, $0, and $717, respectively)

 

 

(500

)

 

 

(888

)

 

 

(949

)

 

 

(2,952

)

Change in fair value of convertible promissory notes (includes related party amounts of $0, $8,818, $0 and $13,196, respectively)

 

 

 

 

 

(34,396

)

 

 

 

 

 

(51,469

)

Change in fair value of warrant liabilities - related party

 

 

 

 

 

(6,151

)

 

 

 

 

 

(43,575

)

Other income (expense)

 

 

329

 

 

 

(20

)

 

 

274

 

 

 

(38

)

Total other income (expense)

 

 

2,282

 

 

 

(41,121

)

 

 

4,352

 

 

 

(97,694

)

Net loss

 

$

(27,902

)

 

$

(53,929

)

 

$

(54,791

)

 

$

(121,816

)

Other comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized loss on marketable securities

 

 

(37

)

 

 

 

 

 

(37

)

 

 

 

Pension and other postemployment benefits

 

 

(3

)

 

 

 

 

 

(4

)

 

 

 

Total comprehensive loss

 

$

(27,942

)

 

$

(53,929

)

 

$

(54,832

)

 

$

(121,816

)

Net loss per share, basic and diluted

 

$

(0.74

)

 

$

(2.03

)

 

$

(1.45

)

 

$

(7.30

)

Weighted-average shares of common stock outstanding, basic and diluted

 

 

37,951,735

 

 

 

26,512,881

 

 

 

37,853,176

 

 

 

16,685,372

 

 

See accompanying notes.

 

2


 

HilleVax, Inc.

Condensed Consolidated Statements of Stockholders’ Equity (Deficit)

(in thousands, except share data)

(unaudited)

 

 

Common Stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Additional
Paid-in
Capital

 

 

Accumulated Other Comprehensive Loss

 

 

Accumulated
Deficit

 

 

Total
Stockholders’
Equity (Deficit)

 

Balance at March 31, 2023

 

 

37,841,987

 

 

$

4

 

 

$

535,221

 

 

$

(282

)

 

$

(291,882

)

 

$

243,061

 

Vesting of restricted shares

 

 

170,304

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock—based compensation

 

 

 

 

 

 

 

 

3,246

 

 

 

 

 

 

 

 

 

3,246

 

Exercise of common stock options

 

 

10,000

 

 

 

 

 

 

80

 

 

 

 

 

 

 

 

 

80

 

Issuance of common stock under stock purchase plan

 

 

26,895

 

 

 

 

 

 

318

 

 

 

 

 

 

 

 

 

318

 

Unrealized loss on marketable securities

 

 

 

 

 

 

 

 

 

 

 

(37

)

 

 

 

 

 

(37

)

Pension and other postemployment benefits

 

 

 

 

 

 

 

 

 

 

 

(3

)

 

 

 

 

 

(3

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(27,902

)

 

 

(27,902

)

Balance at June 30, 2023

 

 

38,049,186

 

 

$

4

 

 

$

538,865

 

 

$

(322

)

 

$

(319,784

)

 

$

218,763

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at March 31, 2022

 

 

6,897,450

 

 

$

1

 

 

$

4,698

 

 

$

 

 

$

(173,071

)

 

$

(168,372

)

Issuance of common stock in connection with initial public offering, net of issuance costs of $20,491

 

 

13,529,750

 

 

 

1

 

 

 

209,514

 

 

 

 

 

 

 

 

 

209,515

 

Conversion of August 2021 Notes and accrued interest into common shares

 

 

10,672,138

 

 

 

1

 

 

 

215,363

 

 

 

 

 

 

 

 

 

215,364

 

Conversion of Takeda Warrant liability into equity

 

 

 

 

 

 

 

 

100,020

 

 

 

 

 

 

 

 

 

100,020

 

Vesting of restricted shares

 

 

212,049

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock—based compensation

 

 

 

 

 

 

 

 

556

 

 

 

 

 

 

 

 

 

556

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(53,929

)

 

 

(53,929

)

Balance at June 30, 2022

 

 

31,311,387

 

 

$

3

 

 

$

530,151

 

 

$

 

 

$

(227,000

)

 

$

303,154

 

 

See accompanying notes.

3


 

HilleVax, Inc.

Condensed Consolidated Statements of Stockholders’ Equity (Deficit) - (Continued)

(in thousands, except share data)

(unaudited)

 

Common Stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Additional
Paid-in
Capital

 

 

Accumulated Other Comprehensive Loss

 

 

Accumulated
Deficit

 

 

Total
Stockholders’
Equity (Deficit)

 

Balance at December 31, 2022

 

 

37,656,037

 

 

$

4

 

 

$

532,499

 

 

$

(281

)

 

$

(264,993

)

 

$

267,229

 

Vesting of restricted shares

 

 

344,872

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock—based compensation

 

 

 

 

 

 

 

 

5,888

 

 

 

 

 

 

 

 

 

5,888

 

Issuance of common stock under stock purchase plan

 

 

26,895

 

 

 

 

 

 

318

 

 

 

 

 

 

 

 

 

318

 

Exercise of common stock options

 

 

21,382

 

 

 

 

 

 

160

 

 

 

 

 

 

 

 

 

160

 

Unrealized loss on marketable securities

 

 

 

 

 

 

 

 

 

 

 

(37

)

 

 

 

 

 

(37

)

Pension and other postemployment benefits

 

 

 

 

 

 

 

 

 

 

 

(4

)

 

 

 

 

 

(4

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(54,791

)

 

 

(54,791

)

Balance at June 30, 2023

 

 

38,049,186

 

 

$

4

 

 

$

538,865

 

 

$

(322

)

 

$

(319,784

)

 

$

218,763

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at December 31, 2021

 

 

6,599,886

 

 

$

1

 

 

$

4,426

 

 

$

 

 

$

(105,184

)

 

$

(100,757

)

Issuance of common stock in connection with initial public offering, net of issuance costs of $20,491

 

 

13,529,750

 

 

 

1

 

 

 

209,514

 

 

 

 

 

 

 

 

 

209,515

 

Conversion of August 2021 Notes and accrued interest into common shares

 

 

10,672,138

 

 

 

1

 

 

 

215,363

 

 

 

 

 

 

 

 

 

215,364

 

Conversion of Takeda Warrant liability into equity

 

 

 

 

 

 

 

 

100,020

 

 

 

 

 

 

 

 

 

100,020

 

Vesting of restricted shares

 

 

509,613

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock—based compensation

 

 

 

 

 

 

 

 

828

 

 

 

 

 

 

 

 

 

828

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(121,816

)

 

 

(121,816

)

Balance at June 30, 2022

 

 

31,311,387

 

 

$

3

 

 

$

530,151

 

 

$

 

 

$

(227,000

)

 

$

303,154

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

See accompanying notes.

4


 

HilleVax, Inc.

Condensed Consolidated Statements of Cash Flows

(in thousands)

(unaudited)

 

 

Six Months Ended
June 30,

 

 

2023

 

 

2022

 

Cash flows from operating activities

 

 

 

 

 

 

Net loss

 

$

(54,791

)

 

$

(121,816

)

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

 

 

 

 

 

 

Depreciation

 

 

106

 

 

 

 

Stock-based compensation

 

 

5,888

 

 

 

828

 

Change in fair value of convertible promissory notes (includes related party
   amounts of $
0 and $13,196, respectively)

 

 

 

 

 

51,469

 

Change in fair value of warrant liabilities - related party

 

 

 

 

 

43,575

 

Amortization of operating lease right-of-use assets

 

 

673