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, 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: 001-39979

 

VOR BIOPHARMA INC.

(Exact Name of Registrant as Specified in its Charter)

 

Delaware

81-1591163

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification No.)

100 Cambridgepark Drive, Suite 101

Cambridge, Massachusetts

02140

(Address of principal executive offices)

(Zip Code)

 

Registrant’s telephone number, including area code: (617) 655-6580

 

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

 

VOR

 

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 ☒

Number of shares of the registrant’s Common Stock outstanding as of November 4, 2022 was 38,666,158.

 


 

Table of Contents

 

 

 

Page

PART I.

FINANCIAL INFORMATION

1

 

 

 

Item 1.

Financial Statements (Unaudited)

1

 

Condensed Consolidated Balance Sheets as of September 30, 2022 and December 31, 2021

1

 

Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Nine Months Ended September 30, 2022 and 2021

2

 

Condensed Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit) for the Three and Nine Months Ended September 30, 2022 and 2021

3

 

Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2022 and 2021

4

 

Notes to Unaudited Condensed Consolidated Financial Statements

5

Item 2.

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

11

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

20

Item 4.

Controls and Procedures

20

 

 

 

PART II.

OTHER INFORMATION

22

 

 

 

Item 1.

Legal Proceedings

22

Item 1A.

Risk Factors

22

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

22

Item 6.

Exhibits

23

 

Signatures

24

 

 

i


 

Note Regarding Company References

Throughout this Quarterly Report on Form 10-Q, the “Company,” “Vor,” “Vor Bio,” “Vor Biopharma Inc.,” “we,” “us,” and “our,” except where the context requires otherwise, refer to Vor Biopharma Inc. and its consolidated subsidiary, and “our board of directors” refers to the board of directors of Vor Biopharma Inc.

Special Note Regarding Forward-Looking Statements

This Quarterly Report on Form 10-Q contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this Quarterly Report on Form 10-Q, including statements regarding our strategy, future operations, future financial position, future revenue, projected costs, prospects, plans, and objectives of management, are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “estimate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions intended to identify statements about the future. These statements speak only as of the date of this Quarterly Report on Form 10-Q and involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.

We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements include, without limitation, statements about:

the timing, progress and results of our preclinical studies and clinical trials of our product candidates, including statements regarding the timing of initiation, enrollment and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available and our research and development programs;
the timing of any submission of filings for regulatory approval of, and our ability to obtain and maintain regulatory approvals for, our product candidates for any indication;
the impacts of the COVID-19 pandemic, which could continue to adversely impact our business, including our preclinical studies and clinical trials;
our ability to identify patients with the diseases treated by our product candidates, and to enroll patients in trials;
our expectations regarding the market acceptance and opportunity for and clinical utility of our product candidates, if approved for commercial use;
our expectations regarding the scope of any approved indication for any product candidate;
our ability to successfully commercialize our product candidates;
our estimates of our expenses, ongoing losses, future revenue, capital requirements and our need for or ability to obtain additional funding before we can expect to generate any revenue from product sales;
our ability to establish or maintain collaborations or strategic relationships;
our ability to identify, recruit and retain key personnel, including executive officers and members of management;
our reliance upon intellectual property licensed from third parties and our ability to obtain such licenses on commercially reasonable terms or at all;
our ability to protect and enforce our intellectual property position for our product candidates, and the scope of such protection;
our financial performance;
the period over which we estimate our existing cash, cash equivalents and marketable securities will be sufficient to fund our future operating expenses and capital expenditure requirements;
our competitive position and the development of and projections relating to our competitors or our industry;
the impact of laws and regulations; and
our expectations regarding the time during which we will be an emerging growth company under the Jumpstart Our Business Startups Act of 2012.

You should read this Quarterly Report on Form 10-Q and the documents that we have filed as exhibits to this Quarterly Report on Form 10-Q completely and with the understanding that our actual future results may be materially different from what we

ii


 

expect. The forward-looking statements contained in this Quarterly Report on Form 10-Q are made as of the date of this Quarterly Report on Form 10-Q, and we do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law. You should refer to the “Summary Risk Factors” section in “Part I. Item 2, Management’s Discussion and Analysis of Financial Condition and Results of Operations” in this Quarterly Report on Form 10-Q and “Part I, Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2021 for a discussion of material factors that may cause our actual results or events to differ materially from those expressed or implied by our forward-looking statements.

 

 

iii


 

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements (Unaudited).

VOR BIOPHARMA INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(UNAUDITED)

 

 

 

September 30,

 

 

December 31,

 

(in thousands, except share amounts)

 

2022

 

 

2021

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

60,827

 

 

$

119,801

 

Marketable securities

 

 

75,240

 

 

 

87,668

 

Prepaid expenses

 

 

4,891

 

 

 

4,836

 

Other current assets

 

 

1,771

 

 

 

2,094

 

Total current assets

 

 

142,729

 

 

 

214,399

 

Restricted cash equivalents

 

 

2,413

 

 

 

2,413

 

Property and equipment, net

 

 

12,963

 

 

 

6,853

 

Operating lease right-of-use assets

 

 

45,390

 

 

 

15,670

 

Other assets

 

 

2,878

 

 

 

3,255

 

Total assets

 

$

206,373

 

 

$

242,590

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

824

 

 

$

1,545

 

Accrued liabilities

 

 

6,288

 

 

 

6,335

 

Operating lease liabilities

 

 

3,757

 

 

 

1,839

 

Other current liabilities

 

 

233

 

 

 

434

 

Total current liabilities

 

 

11,102

 

 

 

10,153

 

Long-term liabilities:

 

 

 

 

 

 

Operating lease liabilities—non-current

 

 

36,537

 

 

 

16,174

 

Total liabilities

 

 

47,639

 

 

 

26,327

 

Stockholders’ equity:

 

 

 

 

 

 

Preferred stock, $0.0001 par value; 10,000,000 shares
   authorized as of September 30, 2022 and December 31, 2021;
   
0 shares issued and outstanding as of September 30,
   2022 and December 31, 2021

 

 

 

 

 

 

Common stock, $0.0001 par value; 400,000,000 
   shares authorized as of September 30, 2022 and December 31, 2021;
   
38,503,966 and 37,375,428 shares issued and
   
38,393,211 and 37,174,741 outstanding as of September 30, 2022 and
   December 31, 2021, respectively

 

 

4

 

 

 

4

 

Additional paid-in capital

 

 

358,215

 

 

 

346,382

 

Accumulated other comprehensive loss

 

 

(1,178

)

 

 

 

Accumulated deficit

 

 

(198,307

)

 

 

(130,123

)

Total stockholders’ equity

 

 

158,734

 

 

 

216,263

 

Total liabilities and stockholders’ equity

 

$

206,373

 

 

$

242,590

 

 

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

1


 

VOR BIOPHARMA INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(UNAUDITED)

 

 

 

Three Months Ended September 30,

 

 

 

Nine Months Ended
September 30,

 

(in thousands, except share and per share amounts)

 

2022

 

 

2021

 

 

 

2022

 

 

2021

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

16,875

 

 

$

12,925

 

 

 

$

47,488

 

 

$

34,836

 

General and administrative

 

 

7,226

 

 

 

5,677

 

 

 

 

21,205

 

 

 

15,876

 

Total operating expenses

 

$

24,101

 

 

$

18,602

 

 

 

$

68,693

 

 

$

50,712

 

Loss from operations

 

$

(24,101

)

 

$

(18,602

)

 

 

$

(68,693

)

 

$

(50,712

)

Other income:

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

313

 

 

 

48

 

 

 

 

509

 

 

 

65

 

Total other income

 

 

313

 

 

 

48

 

 

 

 

509

 

 

 

65

 

Net loss

 

$

(23,788

)

 

$

(18,554

)

 

 

$

(68,184

)

 

$

(50,647

)

Cumulative dividends on redeemable convertible
   preferred stock

 

 

 

 

 

 

 

 

 

 

 

 

(1,228

)

Net loss attributable to common stockholders

 

$

(23,788

)

 

$

(18,554

)

 

 

$

(68,184

)

 

$

(51,875

)

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

 

$

(0.63

)

 

$

(0.50

)

 

 

$

(1.81

)

 

$

(1.62

)

Weighted-average common shares outstanding,
   basic and diluted

 

 

38,009,022

 

 

 

36,934,311

 

 

 

 

37,582,463

 

 

 

32,067,535

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain (loss) on available for sale investments

 

 

148

 

 

 

 

 

 

 

(1,178

)

 

 

 

Total other comprehensive loss

 

 

148

 

 

 

 

 

 

 

(1,178

)

 

 

 

Comprehensive loss attributable to common stockholders

 

$

(23,640

)

 

$

(18,554

)

 

 

$

(69,362

)

 

$

(51,875

)

 

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

2


 

Vor Biopharma Inc.

CONDENSED CONSOLIDATED Statements of redeemable convertible preferred stock and

stockholders’ EQUITY (Deficit)

(Unaudited)

 

 

 

Common
Stock

 

 

Additional
Paid-In

 

 

Accumulated other comprehensive

 

 

Accumulated

 

 

Total
Stockholders’

 

(in thousands, except share amounts)

 

Shares

 

 

Amount

 

 

Capital

 

 

loss

 

 

Deficit

 

 

Equity

 

Balance at December 31, 2021

 

 

37,174,741

 

 

$

4

 

 

$

346,382

 

 

$

0

 

 

$

(130,123

)

 

$

216,263

 

Issuance of common stock upon vesting
    and exercise of stock options

 

 

161,573

 

 

 

 

 

 

247

 

 

 

 

 

 

 

 

 

247

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

1,746

 

 

 

 

 

 

 

 

 

1,746

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

(1,072

)

 

 

 

 

 

(1,072

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(22,737

)

 

 

(22,737

)

Balance at March 31, 2022

 

 

37,336,314

 

 

$

4

 

 

$

348,375

 

 

$

(1,072

)

 

$

(152,860

)

 

$

194,447

 

Issuance of common stock upon vesting
    and exercise of stock options

 

 

74,358

 

 

 

 

 

 

146

 

 

 

 

 

 

 

 

 

146

 

Issuance of common stock from open
    market sales agreement

 

 

95,564

 

 

 

 

 

 

553

 

 

 

 

 

 

 

 

 

553

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

1,741

 

 

 

 

 

 

 

 

 

1,741

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

(254

)

 

 

 

 

 

(254

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(21,659

)

 

 

(21,659

)

Balance at June 30, 2022

 

 

37,506,236

 

 

$

4

 

 

$

350,815

 

 

$

(1,326

)

 

$

(174,519

)

 

$

174,974

 

Issuance of common stock upon vesting
    and exercise of stock options

 

 

126,509

 

 

 

 

 

 

279

 

 

 

 

 

 

 

 

 

279

 

Issuance of common stock from open
    market sales agreement

 

 

760,466

 

 

 

 

 

 

3,792

 

 

 

 

 

 

 

 

 

3,792

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

3,329

 

 

 

 

 

 

 

 

 

3,329

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

148

 

 

 

 

 

 

148

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(23,788

)

 

 

(23,788

)

Balance at September 30, 2022

 

 

38,393,211

 

 

$

4

 

 

$

358,215

 

 

$

(1,178

)

 

$

(198,307

)

 

$

158,734

 

 

 

 

 

Series A-1 Preferred
Stock

 

 

Series A-2 Preferred
Stock

 

 

Series B Preferred
Stock

 

 

Common
Stock

 

 

Additional
Paid-In

 

 

Accumulated

 

 

Total
Stockholders’
Equity

 

(in thousands, except share amounts)

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

(Deficit)

 

Balance at December 31, 2020

 

 

20,000,000

 

 

$

2

 

 

 

107,194,866

 

 

$

42,786

 

 

 

124,519,220

 

 

$

64,548

 

 

 

505,074

 

 

$

1

 

 

$

2,158

 

 

$

(61,224

)

 

$

(59,065

)

Issuance of Series B
    redeemable convertible
    preferred stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

87,259,605

 

 

 

45,375

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conversion of redeemable
    convertible preferred stock
    into common stock upon
    closing of initial public
    offering

 

 

(20,000,000

)

 

 

(2

)

 

 

(107,194,866

)

 

 

(42,786

)

 

 

(211,778,825

)

 

 

(109,923

)

 

 

24,924,501

 

 

 

2

 

 

 

152,709

 

 

 

 

 

 

152,711

 

Issuance of common stock upon closing
    of initial public offering, net of
    offering costs and underwriter fees
    of $
17,132

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

11,302,219

 

 

 

1

 

 

 

186,307

 

 

 

 

 

 

186,308

 

Issuance of common stock
    upon vesting and exercise
    of stock options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

38,216

 

 

 

 

 

 

65

 

 

 

 

 

 

65

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

891

 

 

 

 

 

 

891

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(13,723

)

 

 

(13,723

)

Balance at March 31, 2021

 

 

 

 

$

 

 

 

 

 

$

 

 

 

 

 

$

 

 

 

36,770,010

 

 

$

4

 

 

$

342,130

 

 

$

(74,947

)

 

$

267,187

 

Issuance of common stock
    upon vesting and exercise
    of stock options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

115,362

 

 

 

 

 

 

224

 

 

 

 

 

 

224

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,067

 

 

 

 

 

 

1,067

 

Net loss