SEC Form 10-Q filed by Vor Biopharma Inc.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
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:
(Exact Name of Registrant as Specified in its Charter)
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
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Registrant’s telephone number, including area code: (
Securities registered pursuant to Section 12(b) of the Act:
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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.
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).
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.
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Emerging growth company |
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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 May 8, 2025 was
Table of Contents
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PART I. |
1 |
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Item 1. |
1 |
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Condensed Consolidated Balance Sheets as of March 31, 2025 and December 31, 2024 |
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2 |
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3 |
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Condensed Consolidated Statements of Cash Flows for the Three Months Ended March 31, 2025 and 2024 |
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Notes to Condensed Consolidated Financial Statements (Unaudited) |
5 |
Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
13 |
Item 3. |
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Item 4. |
18 |
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PART II. |
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Item 1. |
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Item 1A. |
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Item 5. |
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Item 6. |
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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,” “might,” “intend,” “target,” “ongoing,” “project,” “estimate,” “believe,” “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, levels of activity, 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:
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 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 “Risk Factors” section in this Quarterly Report and the “Summary Risk Factors” and “Risk Factors” sections in our Annual Report on Form 10-K for the year ended December 31, 2024 for a discussion of material factors that could cause actual results or events to differ materially from the forward-looking statements that we make.
All brand names or trademarks appearing in this Quarterly Report on Form 10-Q are the property of their respective owners.
ii
PART I—FINANCIAL INFORMATION
Item 1. Financial Statements (Unaudited).
VOR BIOPHARMA INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
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March 31, |
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December 31, |
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(in thousands, except share and per share amounts) |
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2025 |
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2024 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
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$ |
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Marketable securities |
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Prepaid expenses |
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Other current assets |
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Total current assets |
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Restricted cash equivalents |
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Property and equipment, net |
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Operating lease right-of-use assets |
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Other assets |
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Total assets |
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$ |
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$ |
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Liabilities and stockholders’ equity |
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Current liabilities: |
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Accounts payable |
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$ |
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$ |
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Accrued liabilities |
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Operating lease liabilities |
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Other current liabilities |
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Total current liabilities |
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Long-term liabilities: |
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Operating lease liabilities—non-current |
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Total liabilities |
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Stockholders’ equity: |
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Preferred stock, $ |
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Common stock, $ |
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Additional paid-in capital |
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Accumulated other comprehensive income |
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Accumulated deficit |
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( |
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity |
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$ |
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$ |
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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)
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Three Months Ended |
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(in thousands, except share and per share amounts) |
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2025 |
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2024 |
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Operating expenses: |
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Research and development |
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$ |
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$ |
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General and administrative |
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Total operating expenses |
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$ |
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$ |
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Loss from operations |
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$ |
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$ |
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Other income: |
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Interest income |
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Total other income |
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Net loss |
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$ |
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$ |
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Net loss per share attributable to common stockholders, |
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$ |
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$ |
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Weighted-average common shares outstanding, |
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Other comprehensive income (loss): |
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Unrealized gain (loss) on available for sale marketable securities |
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( |
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Total other comprehensive income (loss): |
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( |
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Comprehensive loss |
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$ |
( |
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$ |
( |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
2
Vor Biopharma Inc.
CONDENSED CONSOLIDATED Statements of stockholders’ EQUITY
(Unaudited)
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Common |
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Additional |
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Accumulated other |
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Accumulated |
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Total |
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(in thousands, except share amounts) |
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Shares |
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Amount |
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Capital |
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income |
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Deficit |
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Equity |
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Balance at December 31, 2024 |
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$ |
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$ |
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$ |
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$ |
( |
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$ |
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Issuance of common stock upon vesting of RSUs, net of shares withheld for taxes |
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— |
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( |
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— |
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— |
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( |
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Issuance costs for private placement |
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— |
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— |
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— |
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— |
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Stock-based compensation expense |
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— |
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— |
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— |
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— |
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Other comprehensive income |
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— |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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— |
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( |
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( |
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Balance at March 31, 2025 |
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$ |
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$ |
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$ |
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$ |
( |
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$ |
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Common |
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Additional |
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Accumulated other comprehensive |
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Accumulated |
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Total |
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(in thousands, except share amounts) |
Shares |
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Amount |
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Capital |
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loss |
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Deficit |
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Equity |
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Balance at December 31, 2023 |
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$ |
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$ |
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$ |
( |
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$ |
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$ |
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Issuance of common stock upon vesting of RSUs, net of shares withheld for taxes, and exercise of stock options |
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— |
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( |
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— |
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— |
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( |
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Issuance of common stock from at-the-market sales agreement |
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— |
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— |
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— |
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Stock-based compensation expense |
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— |
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— |
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— |
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— |
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Other comprehensive loss |
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— |
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— |
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— |
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( |
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— |
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( |
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Net loss |
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— |
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— |
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— |
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— |
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( |
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( |
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Balance at March 31, 2024 |
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$ |
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$ |
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$ |
( |
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$ |
( |
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$ |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
3
Vor Biopharma Inc.
condensed CONSOLIDATED StatementS of Cash Flows
(unaudited)
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Three Months Ended March 31, |
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(in thousands) |
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2025 |
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2024 |
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Cash flows from operating activities |
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Net loss |
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$ |
( |
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$ |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation expense |
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Non-cash lease expense |
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Stock-based compensation |
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Interest amortization on marketable securities |
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Loss on sale of property and equipment |
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— |
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Changes in operating assets and liabilities: |
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Operating lease liabilities |
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( |
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( |
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Prepaid expenses and other current assets |
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( |
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( |
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Accounts payable, accrued liabilities and other current liabilities |
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( |
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( |
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Other assets |
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( |
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Net cash used in operating activities |
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( |
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Cash flows from investing activities |
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Purchases of marketable securities |
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Proceeds from maturities of marketable securities |
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Purchases of property and equipment |
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( |
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( |
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Net cash (used in) provided by investing activities |
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( |
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Cash flows from financing activities |
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Payment of issuance costs related to private placement |
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( |
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Proceeds from the issuance of common stock from at-the-market sales agreement, net of issuance costs |
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Repurchases of shares for tax withholdings upon vesting of restricted stock unit awards |
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( |
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( |
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Net cash (used in) provided by financing activities |
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( |
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Net (decrease) increase in cash, cash equivalents and restricted cash equivalents |
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( |
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Cash, cash equivalents and restricted cash equivalents, |
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$ |
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$ |
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Cash, cash equivalents and restricted cash equivalents, end of period |
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$ |
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$ |
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Supplemental disclosure of non-cash activities |
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Purchases of property and equipment in accounts payable and accrued liabilities |
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$ |
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$ |
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Financing costs associated with the sale of common stock included in accounts payable and accrued expenses |
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$ |
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$ |
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A reconciliation of the cash, cash equivalents and restricted cash equivalents reported within the condensed consolidated balance sheets that sum to the total of the same amounts shown in the statements of cash flows is as follows:
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For the Three Months Ended March 31, |
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(in thousands) |
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2025 |
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2024 |
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Cash and cash equivalents |
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$ |
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$ |
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Restricted cash equivalents |
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Total cash, cash equivalents and restricted cash equivalents as shown on the |
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$ |
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$ |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
4
VOR BIOPHARMA INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
1. Nature of the Business
Vor Biopharma Inc. (the “Company”) is a clinical-stage cell and genome engineering company that combines a novel patient engineering approach with targeted therapies to provide a single company solution for patients suffering from hematological malignancies. The Company’s proprietary platform leverages its expertise in hematopoietic stem cell (“HSC”) biology, genome engineering and targeted therapy development to genetically modify HSCs to remove surface targets expressed by cancer cells. The Company is headquartered in Cambridge, Massachusetts. The Company was incorporated on
On May 8, 2025, the Company announced the wind-down of its clinical and manufacturing operations, which includes a plan to implement a reduction of the Company’s workforce, as the Company conducts a process to explore strategic alternatives to maximize shareholder value. Refer to Note 13, Subsequent Events, to these interim condensed consolidated financial statements for further discussion of this non-recognized subsequent event.
Risks and Uncertainties
The Company is subject to a number of risks common to development stage companies in the biotechnology industry, including, but not limited to, risks of failure of preclinical studies and clinical trials, dependence on key personnel, protection of proprietary technology, reliance on third party organizations, uncertainty of obtaining regulatory approval for any product candidate that it may develop, development by competitors of technological innovations, compliance with government regulations, adverse macroeconomic conditions and the need to obtain additional financing. In addition, as the Company winds down its clinical and manufacturing operations and explores strategic alternatives, it is subject to additional risks, including, without limitation, risks of unforeseen delays or other challenges in winding down its operations, unintended consequences and unanticipated costs associated with the workforce reduction, such as the loss of institutional knowledge and expertise, attrition beyond the intended number of employees and decreased morale among remaining employees, and the uncertainty of consummating a strategic transaction, any of which may result in further cost-saving initiatives in the future or the business ceasing to continue as a going concern.
The Company anticipates that it will continue to incur significant operating losses as it pursues strategic alternatives aimed at maximizing shareholder value.
Liquidity and Capital Resources
As of March 31, 2025, the Company had $
If, for any reason, the Company utilizes its capital resources more quickly than anticipated or is unable to obtain additional funding on a timely basis and/or complete a strategic transaction, the Company may be required to further revise its business plan and strategy or cease operations. This may limit the strategic options available to the Company. As a result, the Company’s business, financial condition, and results of operations could be materially affected. The accompanying condensed consolidated financial
5
statements do not include any adjustments to the carrying amounts and classification of assets and liabilities that may be necessary if the Company were unable to continue as a going concern.
2. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) issued by the Financial Accounting Standards Board (“FASB”).
Use of Estimates
The preparation of the condensed consolidated financial statements in conformity with GAAP requires the Company’s management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the condensed consolidated financial statements and the reported amount of expenses during the reporting period. Actual results could differ from those estimates. Management considers many factors in selecting appropriate financial accounting policies in developing the estimates and assumptions that are used in the preparation of the condensed consolidated financial statements. Management must apply significant judgment in this process. Management’s estimation process often may yield a range of potentially reasonable estimates and management must select an amount that falls within that range of reasonable estimates. Estimates are used in the following areas, among others: accrued expenses and research and development expenses.
Unaudited Interim Financial Information
The condensed consolidated financial statements of the Company included herein have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). The unaudited condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiary. All intercompany transactions and balances have been eliminated in consolidation. In the opinion of management, the information furnished reflects all adjustments, all of which are of a normal and recurring nature, necessary for a fair presentation of the results for the reported interim periods. The results of operations for interim periods are not necessarily indicative of results to be expected for the full year or any other interim period.
The accompanying condensed consolidated balance sheet as of December 31, 2024 has been derived from the Company’s audited consolidated financial statements for the year ended December 31, 2024. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to GAAP or the rules and regulations of the SEC. However, the Company believes that the disclosures are adequate to make the information presented not misleading. These unaudited interim condensed consolidated financial statements should be read in conjunction with the audited annual consolidated financial statements and related notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 (the “2024 Annual Report”).
During the three months ended March 31, 2025, there have been no changes to the Company’s significant accounting policies as described in the 2024 Annual Report.
3. Marketable Securities
The amortized cost and estimated fair value of marketable securities, by remaining contractual maturity, are as follows:
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March 31, 2025 |
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(in thousands) |
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Amortized Cost |
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Gross Unrealized Holding Gains |
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Gross Unrealized Holding Losses |
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Fair Value |
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Maturing in one year or less |
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U.S. Treasuries |
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$ |
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$ |
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$ |
— |
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$ |
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Total |
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$ |
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$ |
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$ |
— |
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$ |
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6
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December 31, 2024 |
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(in thousands) |
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Amortized Cost |
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Gross Unrealized Holding Gains |
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Gross Unrealized Holding Losses |
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Fair Value |
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Maturing in one year or less |
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U.S. Treasuries |
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$ |
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$ |
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$ |
— |
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$ |
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Maturing after one year through five years |
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U.S. Treasuries |
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— |
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Total |
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$ |
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$ |
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$ |
— |
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$ |
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The Company did not have any individual securities in an unrealized loss position as of March 31, 2025 and December 31, 2024. Additionally, the Company did
4. Fair Value Measurements
The following tables present information about the Company’s financial assets and liabilities measured at fair value on a recurring basis:
|
|
March 31, 2025 |
|
|||||||||||||
(in thousands) |
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash equivalents |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Money market funds |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
Marketable securities |
|
|
|
|
|
|
|
|
|
|
|
|
||||
U.S. Treasuries |
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
Total marketable securities |
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
Restricted cash equivalents |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Money market funds |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Total |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|||
|
|
December 31, 2024 |
|
|||||||||||||
(in thousands) |
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash equivalents |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Money market funds |
|
$ |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
|
||
Marketable securities |
|
|
|
|
|
|
|
|
|
|
|
|
||||
U.S. Treasuries |
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
Total marketable securities |
|
|
— |
|
|
|
|
|
|
— |
|
|
|
|
||
Restricted cash equivalents |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Money market funds |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
||
Total |
|
$ |
|
|
$ |
|
|
$ |
— |
|
|
$ |
|
|||
The fair value of the Company’s cash equivalents and restricted cash equivalents is based on quoted market prices in active markets with
Prepaid expenses, accounts payable and accrued expenses are stated at their respective historical carrying values, which approximate fair value due to their short-term nature.
7
5. Property and Equipment, Net
Property and equipment, net consisted of the following:
|
|
March 31, |
|
|
December 31, |
|
||
(in thousands) |
|
2025 |
|
|
2024 |
|
||
Laboratory equipment |
|
$ |
|
|
$ |
|
||
Manufacturing equipment |
|
|
|
|
|
|
||
Computer equipment |
|
|
|
|
|
|
||
Furniture, fixtures and other |
|
|
|
|
|
|
||
Construction in progress |
|
|
|
|
|
|
||
Total |
|
|
|
|
|
|
||
Less: Accumulated depreciation |
|
|
( |
) |
|
|
( |
) |
Property and equipment, net |
|
$ |
|
|
$ |
|
||
Depreciation expense for the three months ended March 31, 2025 and 2024 was $
6. Accrued Liabilities
Accrued liabilities consisted of the following:
|
|
March 31, |
|
|
December 31, |
|
||
(in thousands) |
|
2025 |
|
|
2024 |
|
||
Employee-related expenses |
|
$ |
|
|
$ |
|
||
Professional fees |
|
|
|
|
|
|
||
Clinical expenses |
|
|
|
|
|
|
||
Manufacturing expenses |
|
|
|
|
|
|
||
Research and development expenses |
|
|
|
|
|
|
||
Other |
|
|
|
|
|
|
||
Total accrued liabilities |
|
$ |
|
|
$ |
|
||
7. Stockholders' Equity
Private Placement
On December 27, 2024, the Company entered into a purchase agreement with certain institutional investors (collectively, the "Purchasers"), pursuant to which the Company issued and sold to the Purchasers in a private placement an aggregate of (i)
The Warrants have an exercise price of $
The Company determined that the Warrants are freestanding instruments that do not meet the definition of a liability or derivative. The Warrants are indexed to the Company’s common stock and meet all other conditions for equity classification. Accordingly, the Warrants are classified as equity and accounted for as a component of additional paid-in capital at the time issued. The Company also determined that the Warrants should be included in the determination of diluted net loss per share if their impact is
8
dilutive. However, they are not included within diluted net loss per share for the period ended March 31, 2025 as the effect would be antidilutive.
As of March 31, 2025,
8. Stock-Based Compensation
2023 Inducement Plan
As of March 31, 2025, the Company had
2021 Equity Incentive Plan
As of March 31, 2025, the Company had
Stock Options
The Company’s stock options generally
|
|
Three Months Ended March 31, |
|
|||||
|
|
2025 |
|
|
2024 |
|
||
Expected term (in years) |
|
|
|
|
|
|
||
Expected volatility |
|
|
% |
|
|
% |
||
Risk-free interest rate |
|
|
% |
|
|
% |
||
Dividend yield |
|
|
|
|
|
|
||
During the three months ended March 31, 2025 and 2024, the Company granted new stock options to purchase
As of March 31, 2025, there were
Option Repricing
On February 3, 2025, the Company's board of directors approved a stock option repricing (the “Option Repricing”) whereby the exercise price of certain outstanding options to purchase shares of the Company’s common stock was reduced to $
Restricted Stock Units
During the three months ended March 31, 2025 and 2024, the Company granted
9
March 31, 2025, total unrecognized compensation expense related to restricted stock units was $
Employee Stock Purchase Plan
As of March 31, 2025, the Company had
The Company did
Stock-Based Compensation
Stock-based compensation expense was allocated as follows:
|
|
Three Months Ended March 31, |
|
|||||
(in thousands) |
|
2025 |
|
|
2024 |
|
||
Research and development |
|
$ |
|
|
$ |
|
||
General and administrative |
|
|
|
|
|
|
||
Total stock-based compensation expense |
|
$ |
|
|
$ |
|
||
9. Leases
Cambridgepark Lease Amendments
On June 15, 2021, the Company entered into the first lease amendment (“First Lease Amendment”) and second lease amendment (“Second Lease Amendment” and, together with the First Lease Amendment, the “Lease Amendments”) with PPF Off 100 Cambridge Park Drive, LLC (the “Landlord”). The Lease Amendments amended the Company’s lease agreement for its corporate office and laboratory facilities with the Landlord in Cambridge, Massachusetts to add additional leased space in the same building (the “Amended Cambridgepark Lease”).
The First Lease Amendment and Second Lease Amendment commenced for accounting purposes on
Payments due associated with the Lease Amendments include fixed and variable payments. Variable payments relate to the Company’s share of the Landlord’s operating costs associated with the underlying assets and are recognized when the event on which those payments are assessed occurs. The Amended Cambridgepark Lease does not contain a residual value guarantee. The Lease Amendments term end dates are coterminous with the existing lease agreement. In conjunction with the Lease Amendments, the Company was required to increase its irrevocable standby letter of credit to $
For further information regarding the Company’s Cambridgepark lease, refer to Note 9 to the consolidated financial statements included in the 2024 Annual Report.
The elements of lease expense were as follows:
|
|
Three Months Ended March 31, |
|
|||||
(in thousands) |
|
2025 |
|
|
2024 |
|
||
Operating lease cost |
|
|
|
|
$ |
|
||
Variable lease cost |
|
|
|
|
|
|
||
Total lease cost |
|
$ |
|
|
$ |
|
||
10
Amounts reported in the condensed consolidated balance sheets and the weighted-average lease term and discount rate information were as follows:
(in thousands except weighted-average amounts) |
|
March 31, 2025 |
|
|
December 31, 2024 |
|
||
Assets |
|
|
|
|
|
|
||
Operating lease right-of-use assets |
|
$ |
|
|
$ |
|
||
Liabilities |
|
|
|
|
|
|
||
Operating lease liabilities, current |
|
$ |
|
|
$ |
|
||
Operating lease liabilities, non-current |
|
|
|
|
|
|
||
Total lease liabilities |
|
$ |
|
|
$ |
|
||
Weighted-Average Lease Term and Discount Rate |
|
|
|
|
|
|
||
Weighted-average remaining lease term (years) |
|
|
|
|
|
|||
Weighted-average discount rate |
|
|
% |
|
|
% |
||
The following table represents other lease activity:
|
|
Three Months Ended March 31, |
|
|||||
(in thousands) |
|
2025 |
|
|
2024 |
|
||
Other Information |
|
|
|
|
|
|
||
Cash paid for amounts included in the measurement of lease liabilities |
|
|
|
|
|
|
||
Operating cash flows for operating leases |
|
$ |
|
|
$ |
|
||
10. Significant Agreements
Since December 31, 2024, there have been no material changes to the key terms of the Company’s license agreements. For further information regarding the Company’s existing license agreements, refer to Note 10 to the consolidated financial statements included in the 2024 Annual Report.
11. Net Loss Per Share
The following table sets forth the computation of the Company’s basic and diluted net loss per share for the three months ended March 31, 2025 and 2024:
|
|
Three Months Ended March 31, |
|
|||||
(in thousands, except share and per share amounts) |
|
2025 |
|
|
2024 |
|
||
Numerator: |
|
|
|
|
|
|
||
Net loss attributable to common stockholders |
|
$ |
( |
) |
|
$ |
( |
) |
Denominator: |
|
|
|
|
|
|
||
Weighted-average number of common shares outstanding, basic and diluted |
|
|
|
|
|
|
||
Net loss per share attributable to common stockholders, basic and diluted |
|
$ |
( |
) |
|
$ |
( |
) |
The Company’s potentially dilutive securities were stock options, unvested restricted stock, restricted stock units, and warrants. Based on the amounts outstanding as of March 31, 2025 and 2024, the Company excluded the following potential common shares from the computation of diluted net loss per share attributable to common stockholders because including them would have had an anti-dilutive effect:
|
|
As of March 31, |
|
|||||
|
|
2025 |
|
|
2024 |
|
||
Options to purchase common stock |
|
|
|
|
|
|
||
Unvested restricted stock |
|
|
— |
|
|
|
|
|
Restricted stock units |
|
|
|
|
|
|
||
Warrants |
|
|
|
|
|
— |
|
|
12. Segments
11
The Company operates and manages its business as
The following table is a summary of the segment profit or loss, including significant segment expenses (in thousands):
|
|
Three Months Ended |
|
|||||
|
|
2025 |
|
|
2024 |
|
||
Segment expenses: |
|
|
|
|
|
|
||
Trem-cel(a) |
|
$ |
|
|
$ |
|
||
VCAR33(a) |
|
|
|
|
|
|
||
Other research and development(a) |
|
|
|
|
|
|
||
Salaries and benefits |
|
|
|
|
|
|
||
General corporate activities |
|
|
|
|
|
|
||
Other segment items(b) |
|
|
|
|
|
|
||
Segment expenses: |
|
|
|
|
|
|
||
Segment net loss |
|
|
( |
) |
|
|
( |
) |
(a) Includes only external research and development expenditures.
(b) Other segment items are primarily comprised of taxes, interest income on marketable securities and certain non-cash expenses such as stock-based compensation, depreciation expense, and non-cash lease expense.
The measure of segment assets is reported on the consolidated balance sheet as total assets. The CODM additionally reviews cash, cash equivalents and marketable securities when reviewing segment assets. As of March 31, 2025, the Company’s cash, cash equivalents and marketable securities were $
13. Subsequent Events
On May 5, 2025, the Company’s board of directors approved the wind down of the Company’s clinical and manufacturing operations as the Company conducts a process to explore strategic alternatives to maximize shareholder value. The Company publicly announced this plan on May 8, 2025.
In conjunction with this strategic process, the Company also announced a reduction of its workforce by
12
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
You should read the following discussion and analysis of our financial condition and results of operations together with the unaudited condensed consolidated financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q and with the consolidated financial statements and related notes included in our Annual Report on Form 10-K for the year ended December 31, 2024 (the “2024 Annual Report”). Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the section titled “Risk Factors” in our 2024 Annual Report and in other reports we have filed or may file with the SEC, our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.
Overview
Vor Bio is a clinical-stage company harnessing the power of cell and genome engineering to develop potentially transformative therapies in acute myeloid leukemia (“AML”), a devastating disease with few treatment options. AML is the most common type of acute leukemia in adults and one of the deadliest and most aggressive blood cancers, affecting approximately 20,000 newly diagnosed patients each year in the United States.
On May 8, 2025, we announced that we are winding down our clinical and manufacturing operations, including our ongoing clinical trials, and conducting a process to explore strategic alternatives to maximize shareholder value, including, among other alternatives, a potential sale or licensing of our assets, an in-license arrangement, sale of the company, business combination, merger or other strategic action. In conjunction with this strategic process, we also announced a reduction of our workforce by 147 full-time employees, or approximately 95% of our then-current employee base. The reduction of workforce is expected to result in approximately $10.9 million in severance costs and such costs are primarily expected to be incurred in the second quarter of 2025. We estimate we will incur additional costs related to our wind down activities, including but not limited to impairment charges, losses on disposals of assets, contract termination costs and other incremental expenses as a result of the strategic process. The amount of such charges and costs could be material to our results of operations and financial condition. The exact amounts and timing of recognition of such charges and costs is not yet known.
We have incurred significant operating losses since inception, including net losses of $32.5 million for the three months ended March 31, 2025 and $116.9 million for the year ended December 31, 2024. As of March 31, 2025, we had an accumulated deficit of $489.5 million.
As of March 31, 2025, we had cash, cash equivalents and marketable securities of $60.0 million. We do not expect that our cash, cash equivalents and marketable securities at March 31, 2025 will enable us to fund our operations beyond one year from the date that these condensed consolidated financial statements are issued.
Critical Accounting Estimates
Our management’s discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with United States generally accepted accounting principles. The preparation of our condensed consolidated financial statements requires us to make judgments and estimates that affect the reported amounts of assets, liabilities, costs, and expenses, and the disclosure of contingent assets and liabilities in our condensed consolidated financial statements. We base our estimates on historical experience, known trends and events, and various other factors that we believe to be reasonable under the circumstances. Actual results may differ from these estimates under different assumptions or conditions. On an ongoing basis, we evaluate our judgments and estimates in light of changes in circumstances, facts, and experience. The effects of material revisions in estimates, if any, will be reflected in the condensed consolidated financial statements prospectively from the date of change in estimates. There have been no material changes to our critical accounting estimates from those described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our 2024 Annual Report.
Financial Operations Overview
Revenue
We have not generated any revenue since our inception and do not expect to generate any revenue from the sale of products in the near future, if at all. If our development efforts for any product candidates that we may in-license as part of our strategic review process are successful and result in marketing approval, or if we enter into collaboration or license agreements with third parties, we may generate revenue in the future from a combination of product sales or payments from such agreements.
13
Expenses
Research and Development Expenses
Research and development expenses consist primarily of external and internal expenses incurred in connection with our research and development activities, including our drug discovery efforts and the development of our product candidates. External expenses include:
Internal expenses include:
We expense research and development costs as incurred. We recognize external development costs based on an evaluation of the progress to completion of specific tasks using information provided to us by our vendors. Payments for these activities are based on the terms of the individual agreements, which may differ from the pattern of costs incurred, and are reflected in our condensed consolidated financial statements as prepaid expenses or accrued research and development expenses. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are deferred and capitalized, even when there is no alternative future use for the research and development. The capitalized amounts are expensed as the related goods are delivered or the services are performed.
A significant portion of our research and development costs have been external costs, which we track by program.
Research and development activities have been central to our business model, prior to our decision to wind down clinical and manufacturing operations in May 2025. We generally expect that our research and development expenses will decrease significantly as we wind down these operations. We may also incur other charges or cash expenditures due to events that may occur as a result of, or associated with, our wind down of clinical and manufacturing operations and review of strategic alternatives. The exact amounts of the charges and costs that we expect to incur, and the timing thereof, are currently unknown and such costs and charges could be material to our results of operation and financial condition.
The successful development of our product candidates or any product candidates that we may in-license as part of our strategic review in the future is highly uncertain. Therefore, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the development and commercialization of any of our product candidates. We are also unable to predict when, if ever, material net cash inflows will commence from the sale of our product candidates, if approved. This is due to the numerous risks and uncertainties associated with developing product candidates, many of which are outside of our control, including the uncertainty of successfully completing clinical trials with safety, tolerability and efficacy profiles that are satisfactory to the FDA or any comparable foreign regulatory authority; the timing, receipt and terms of any regulatory approvals from applicable regulatory authorities; establishing commercial manufacturing capabilities or making arrangements with third-party manufacturers; government regulation and regulatory guidance; obtaining, maintaining, defending and enforcing intellectual property rights; launching commercial sales of product candidates, if approved; and the availability of funding sufficient for foreseeable and unforeseeable operating expenses and capital expenditure requirements. Any changes in the outcome of any of these variables could mean a significant change in the costs and timing associated with the development of our product candidates.
General and Administrative Expenses
General and administrative expenses consist primarily of personnel-related costs, including salaries, bonuses, benefits and stock-based compensation expenses for employees involved in our executive, finance, corporate, business development and administrative functions, as well as expenses for outside professional services, including legal, audit, accounting and tax-related services and other consulting fees, facility-related expenses, which include depreciation costs and other allocated expenses for rent and maintenance of facilities, insurance costs, recruiting costs, travel expenses and other general administrative expenses.
We generally expect that our general and administrative expenses will decrease significantly as we wind down our clinical and manufacturing operations, including through the implementation of our workforce reduction in May 2025. However, we may also
14
incur other charges or cash expenditures due to events that may occur as a result of, or associated with, our wind down of clinical and manufacturing operations and review of strategic alternatives. The exact amounts of the charges and costs that we expect to incur, and the timing thereof, are currently unknown and such costs and charges could be material to our results of operation and financial condition.
Other Income
Interest Income
Interest income consists of interest income earned on our cash, cash equivalents, restricted cash equivalents and marketable securities held in financial institutions.
Results of Operations
Comparison of Three Months Ended March 31, 2025 and 2024
The following table summarizes our results of operations for the periods indicated (amounts in thousands):
|
|
Three Months Ended |
|
|
|
|
||||||
|
|
2025 |
|
|
2024 |
|
|
Change |
|
|||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|||
Research and development |
|
$ |
26,701 |
|
|
$ |
24,322 |
|
|
$ |
2,379 |
|
General and administrative |
|
|
6,590 |
|
|
|
8,004 |
|
|
|
(1,414 |
) |
Total operating expenses |
|
|
33,291 |
|
|
|
32,326 |
|
|
|
965 |
|
Loss from operations |
|
|
(33,291 |
) |
|
|
(32,326 |
) |
|
|
(965 |
) |
Other income: |
|
|
|
|
|
|
|
|
|
|||
Interest income |
|
|
805 |
|
|
|
1,522 |
|
|
|
(717 |
) |
Total other income |
|
|
805 |
|
|
|
1,522 |
|
|
|
(717 |
) |
Net loss |
|
$ |
(32,486 |
) |
|
$ |
(30,804 |
) |
|
$ |
(1,682 |
) |
Research and Development Expenses
The following table summarizes our research and development expenses incurred for the periods indicated (amounts in thousands):
|
|
Three Months Ended |
|
|
|
|
||||||
|
|
2025 |
|
|
2024 |
|
|
Change |
|
|||
External research expenses: |
|
|
|
|
|
|
|
|
|
|||
Trem-cel |
|
$ |
6,382 |
|
|
$ |
4,861 |
|
|
$ |
1,521 |
|
VCAR33 |
|
|
3,636 |
|
|
|
2,600 |
|
|
|
1,036 |
|
Other research and development |
|
|
2,995 |
|
|
|
3,117 |
|
|
|
(122 |
) |
Internal research expenses: |
|
|
|
|
|
|
|
|
|
|||
Salaries and benefits (including stock-based compensation) |
|
|
10,099 |
|
|
|
10,468 |
|
|
|
(369 |
) |
Manufacturing, facilities, and other research expenses |
|
|
3,589 |
|
|
|
3,276 |
|
|
|
313 |
|
Total research and development expenses |
|
$ |
26,701 |
|
|
$ |
24,322 |
|
|
$ |
2,379 |
|
Research and development expenses were $26.7 million for the three months ended March 31, 2025, compared to $24.3 million for the three months ended March 31, 2024. The increase of $2.4 million was primarily due to an increase in clinical trial costs to support our trem-cel and VCAR33 programs as well as an increase in lab supplies and consumables.
General and Administrative Expenses
General and administrative expenses were $6.6 million for the three months ended March 31, 2025, compared to $8.0 million for the three months ended March 31, 2024. The decrease of $1.4 million was primarily due to a decrease in stock-based compensation expense and personnel costs.
Other Income
Other income decreased by $0.7 million during the three months ended March 31, 2025, compared to the three months ended March 31, 2024. The decrease in other income was due to decreases in interest earned from our cash, cash equivalents, restricted cash
15
equivalents and marketable securities as we held lower balances of cash, cash equivalents and marketable securities during the 2025 period.
Liquidity and Capital Resources
Sources of Liquidity
Since our inception, we have not recognized any revenue and have incurred operating losses and negative cash flows from our operations. We have not yet commercialized any product and we do not expect to generate revenue from sales of any products for several years, if at all. We have funded our operations primarily through the sale of equity securities and have received aggregate net proceeds from financing transactions of approximately $517.1 million as of March 31, 2025.
On March 20, 2025, we filed a universal shelf registration statement (the “Shelf Registration Statement”), to provide for aggregate offerings of up to $350.0 million of common stock, preferred stock, debt securities, warrants or any combination thereof. As of March 31, 2025, $350.0 million remains available under this Shelf Registration Statement, including $119.7 million reserved for at-the market offerings discussed below.
However, as of the date of filing our Shelf Registration Statement, our public float was less than $75 million. As a result, we are subject to the limitations of General Instruction I.B.6 to Form S-3 until such time as our public float exceeds $75 million, which means we only have the capacity to sell shares up to one-third of our public float under shelf registration statements in any twelve-month period. We will remain constrained by the limitations of General Instruction I.B.6 to Form S-3 until such time as our public float exceeds $75 million, at which time the number of securities we may sell under a Form S-3 registration statement will no longer be constrained by the limitations of General Instruction I.B.6 to Form S-3.
At-the-Market Sales Agreement
In December 2022, we entered into a Sales Agreement with Stifel, Nicolaus & Company, Incorporated (“Stifel”) as the agent (the "Stifel ATM Facility"). Pursuant to the Stifel ATM Facility, we may offer and sell shares of common stock with an aggregate value of up to $125.0 million, subject to our filing a prospectus supplement to the base prospectus included in our Shelf Registration Statement covering the offer and sale of shares of our common stock pursuant to the Stifel ATM Facility and subject to the limitations of General Instruction I.B.6 of Form S-3. We will pay Stifel a commission of up to 3.0% of the gross proceeds of any common stock sold through Stifel. We did not sell any shares of our common stock under the Stifel ATM Facility during the three months ended March 31, 2025. As of March 31, 2025, $119.7 million remained available to be sold under the Stifel ATM Facility.
Cash Requirements
As of March 31, 2025, we had cash, cash equivalents and marketable securities of $60.0 million. Depending on the outcome of our strategic review process, we may need to raise substantial additional capital to fund our future operations. However, we cannot guarantee that we will be able to obtain sufficient additional funding or that if we do obtain additional funding, that such funding will be obtainable on terms satisfactory to us.
Based on our current business plan and current capital resources, management has concluded that there is substantial doubt regarding our ability to continue as a going concern for a period of 12 months from the date of issuance of the accompanying condensed consolidated financial statements. The accompanying financial statements have been prepared on a going concern basis and do not include any adjustments to the carrying amounts and classification of assets and liabilities that may be necessary if we were unable to continue as a going concern.
We expect our expenses to decrease substantially in connection with the wind down of our clinical and manufacturing operations. However, we may incur substantial additional expenses and other charges as we conduct our strategic alternatives review and evaluate and seek to consummate strategic transactions to maximize shareholder value.
If we are successful in consummating a strategic transaction that enables us to continue to develop our current or new product candidates, we will require substantial additional funding to expand our operations, hire additional personnel, initiate and successfully complete preclinical studies and clinical trials, obtain marketing approval and generate revenue from sales of our product candidates, if approved, and protect our intellectual property. We would expect to finance our operations through the public or private sale of our equity, government or private party grants, debt financings or other capital sources, including potential collaborations with other companies or other strategic transactions. Because of the uncertain outcome of our strategic review process and the numerous risks and uncertainties associated with product development, we cannot predict the timing or amount of our future expenses, and there is no assurance that we will ever be profitable or generate positive cash flow from operating activities.
If, for any reason, we utilize our capital resources more quickly than anticipated or are unable to obtain additional funding on a timely basis and/or complete a strategic transaction, we may be required to further revise our business plan and strategy or cease
16
operations. This may limit the strategic options available to us. As a result, our business, financial condition, and results of operations could be materially affected.
We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements that have or are reasonably likely to have a material current or future effect on our financial condition, revenues or expenses, results of operations, liquidity, cash requirements or capital resources.
Cash Flows
The following table provides information regarding our cash flows for the periods presented (in thousands):
|
|
Three Months Ended March 31, |
|
|||||
|
|
2025 |
|
|
2024 |
|
||
Net cash used in operating activities |
|
$ |
(31,066 |
) |
|
$ |
(30,465 |
) |
Net cash (used in) provided by investing activities |
|
|
(230 |
) |
|
|
43,973 |
|
Net cash (used in) provided by financing activities |
|
|
(606 |
) |
|
|
96 |
|
Net (decrease) increase in cash, cash equivalents and restricted cash equivalents |
|
$ |
(31,902 |
) |
|
$ |
13,604 |
|
Operating Activities
Net cash used in operating activities was $31.1 million for the three months ended March 31, 2025, reflecting a net loss of $32.5 million and net cash used of $2.6 million for operating assets and liabilities, which were partially offset by non-cash charges of $4.1 million. The non-cash charges primarily consisted of stock-based compensation expense of $1.9 million, non-cash lease expense of $1.3 million and depreciation expense of $0.8 million.
Net cash used in operating activities was $30.5 million for the three months ended March 31, 2024, reflecting a net loss of $30.8 million and net cash used of $4.1 million for operating assets and liabilities, which were partially offset by non-cash charges of $4.5 million. The non-cash charges primarily consisted of stock-based compensation expense of $3.1 million, non-cash lease expense of $1.2 million and depreciation expense of $0.9 million, partially offset by $0.8 million of non-cash interest earned on marketable securities.
The $0.6 million increase in net cash used in operating activities for the three months ended March 31, 2025 compared to the three months ended March 31, 2024 was primarily due to an increase in research and development expenses and decrease in stock-based compensation, partially offset by differences in the timing of payments for costs incurred during each respective period.
Investing Activities
Net cash used in investing activities was $0.2 million for the three months ended March 31, 2025, which consisted primarily of purchases of $0.2 million of property and equipment. Net cash provided by investing activities was $44.0 million for the three months ended March 31, 2024, which consisted of proceeds of $54.0 million from the maturity of marketable securities, partially offset by purchases of $9.9 million of marketable securities and $0.1 million of property and equipment.
Financing Activities
Net cash used in financing activities was $0.6 million for the three months ended March 31, 2025, which consisted of $0.5 million of issuance costs related to the December 2024 private placement and $0.1 million of taxes paid related to net share settlement of equity awards. Net cash provided by financing activities was $0.1 million for the three months ended March 31, 2024, which consisted of proceeds from the issuance of common stock under the Stifel ATM Facility of $0.3 million, partially offset by $0.2 million of taxes paid related to net share settlement of equity awards.
Contractual Obligations and Other Commitments
Contractual obligations relate to future minimum lease payments for existing non-cancellable leases primarily relating to corporate office and laboratory real estate, with terms expiring through February 2030. During the three months ended March 31, 2025, there were no significant changes in contractual obligations and commitments from that described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Contractual Obligations and Other Commitments” in our 2024 Annual Report.
Other commitments include license and collaboration agreements we have entered into with certain parties. Such arrangements require ongoing payments, including payments upon the achievement of certain development, regulatory and commercial milestones, receipt of sublicense income, as well as royalties on commercial sales. Payments under these arrangements are expensed as incurred.
We also have agreements with certain vendors for various services, including services related to clinical operations and support, which we are not contractually able to terminate for convenience and avoid any and all future obligations to the vendors. Under such
17
agreements, we are contractually obligated to make certain payments to vendors to reimburse them for their unrecoverable outlays incurred prior to cancellation. The exact amounts of such obligations are dependent on the timing of termination and the exact terms of the relevant agreement and cannot be reasonably estimated. We do not include these payments in this summary as they are not fixed and estimable.
As discussed within Note 13, Subsequent Events, to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q, on May 5, 2025, the Company’s board of directors approved the wind down of our clinical and manufacturing operations. As a result, our existing contractual obligations and commitments may be renegotiated, amended or altered as we wind down operations and explore strategic alternatives to maximize shareholder value. The estimated impact of such activities was described within our Current Report on Form 8-K filed on May 8, 2025.
Recent Accounting Pronouncements
There are no new significant recent accounting pronouncements which may materially impact our financial statements.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
We are a smaller reporting company as defined by Item 10 of Regulation S-K and are not required to provide the information otherwise required under this item.
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer and our Chief Financial Officer, evaluated, as of the end of the period covered by this Quarterly Report on Form 10-Q, the effectiveness of our disclosure controls and procedures. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives, and our management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
Based on the evaluation of our disclosure controls and procedures as of March 31, 2025, our Chief Executive Officer and our Chief Financial Officer concluded that our disclosure controls and procedures as of such date were effective at the reasonable assurance level.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended March 31, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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PART II—OTHER INFORMATION
Item 1. Legal Proceedings.
We are not currently a party to any material legal proceedings. From time to time, we may become involved in other litigation or legal proceedings relating to claims arising from the ordinary course of business.
Item 1A. Risk Factors.
Our business is subject to risks and events that, if they occur, could adversely affect our financial condition and results of operations and the trading price of our securities. Except as set forth below, there have been no material changes to the risk factors disclosed in “Part I. Item 1A. Risk Factors” in our 2024 Annual Report.
If we fail to satisfy all applicable requirements of Nasdaq and it determines to delist our common stock, the delisting could adversely affect the market liquidity of our common stock and the market price of our common stock could decrease.
To maintain the listing of our common stock on Nasdaq, we are required to meet certain listing requirements, including a minimum closing bid price of $1.00 per share. On April 22, 2025, we received notice from Nasdaq that we are no longer in compliance with Nasdaq’s Listing Rule 5450(a)(1) because the closing bid price of our common stock had fallen below $1.00 per share for 30 consecutive days. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we have an initial period of 180 calendar days, or until October 20, 2025 (the “Compliance Date”), to regain compliance with the minimum bid price requirement. To regain compliance, the closing bid price of our common stock must be at least $1.00 per share for a minimum of 10 consecutive business days before the Compliance Date.
If our common stock does not achieve compliance by the Compliance Date, we may be eligible for an additional 180-day period to regain compliance if we apply to transfer the listing of our common stock to the Nasdaq Capital Market. To qualify, we would be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards, with the exception of the bid price requirement, and provide written notice to Nasdaq of our intention to cure the deficiency during the second compliance period by effecting a reverse stock split, if necessary.
There can be no assurance that we will maintain compliance with the requirements for listing our common stock on Nasdaq. If we are unable to satisfy the Nasdaq criteria for continued listing, our common stock would be subject to delisting. A delisting of our common stock could negatively impact us by, among other things, (i) reducing the liquidity and market price of our common stock; (ii) reducing the number of investors willing to hold or acquire our common stock, which could negatively impact our ability to raise equity financing; (iii) decreasing the amount of news and analyst coverage of us; (iv) limiting our ability to issue additional securities or obtain additional financing in the future; (v) limiting our ability to use a registration statement to offer and sell freely tradable securities, thereby preventing us from accessing the public capital markets; and (vi) impairing our ability to provide equity incentives to our employees. In addition, delisting from Nasdaq may negatively impact our reputation and, consequently, our business.
Our strategic review and workforce reduction may not achieve our intended outcomes.
In May 2025, we announced the initiation of a process to explore a range of strategic alternatives aimed at maximizing both near- and long-term shareholder value, which could include, among other alternatives, a potential sale or licensing of assets, a sale of the Company, a business combination, a merger or other strategic action. We expect to devote substantial time and resources to exploring strategic alternatives we believe may drive shareholder value. Despite devoting significant efforts to identify and evaluate potential strategic alternatives, there can be no assurance that this strategic review process will result in us pursuing any transaction or that any transaction, if pursued, will be completed on attractive terms or at all. We have not set a timetable for completion of this strategic review process, and our Board of Directors has not approved a definitive course of action beyond the wind-down of our clinical and manufacturing operations and the exploration of strategic alternatives. Additionally, there can be no assurances that any particular course of action, business arrangement or transaction, or series of transactions will be pursued, successfully consummated or lead to increased shareholder value.
In connection with the strategic review, we also implemented certain actions to reduce operational and workforce expenses that are no longer deemed core to our ongoing operations in order to extend our capital resources, including the wind down of our clinical and manufacturing operations. We may experience unforeseen delays or other challenges in implementing these changes, which could adversely impact our timelines and operations and, ultimately, our ability to develop product candidates for potential commercialization. The workforce reduction may result in unintended consequences and costs, such as the loss of institutional knowledge and expertise, attrition beyond the intended number of employees, decreased morale among our remaining employees, and the risk that we may not achieve the anticipated benefits of the reduction in force. Furthermore, we may undertake further similar
19
cost-saving initiatives in the future, which may include additional restructuring or workforce reductions. These types of cost-reduction activities can be complex and result in unintended consequences and costs, which could adversely impact our business. In addition, we estimate we will incur additional costs related to our wind down activities, including but not limited to impairment charges, losses on disposals of assets, contract termination costs and other incremental expenses as a result of the strategic process. The amount of such charges and costs could be material to our results of operations and financial condition. The exact amounts and timing of recognition of such charges and costs is not yet known.
Item 5. Other Information
During the quarter ended March 31, 2025, no director or officer, as defined in Rule 16a-1(f),
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Item 6. Exhibits.
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Incorporated by Reference |
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Exhibit Number |
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Description |
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Form |
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File No. |
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Exhibit Number |
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Filing Date |
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Filed Herewith |
3.1 |
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Amended and Restated Certificate of Incorporation of the Registrant |
|
8-K |
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001-39979 |
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3.1 |
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February 9, 2021 |
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3.2 |
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8-K |
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001-39979 |
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3.2 |
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February 9, 2021 |
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4.1 |
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S-1/A |
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333-252175 |
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4.1 |
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February 1, 2021 |
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4.2 |
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S-1/A |
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333-252175 |
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4.2 |
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February 1, 2021 |
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31.1 |
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X |
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32.1† |
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X |
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101.INS |
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Inline XBRL Instance Document
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X |
101.SCH |
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Inline XBRL Taxonomy Extension Schema Document
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X |
101.CAL |
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Inline XBRL Taxonomy Extension Calculation Linkbase Document
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X |
101.DEF
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Inline XBRL Taxonomy Extension Definition Linkbase Document
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X |
101.LAB
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Inline XBRL Taxonomy Extension Label Linkbase Document
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X |
101.PRE |
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Inline XBRL Taxonomy Extension Presentation Linkbase Document
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|
X |
104 |
|
The cover page from the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, formatted in Inline XBRL. |
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+ Indicates management contract or compensatory plan.
† The certifications furnished in Exhibit 32.1 hereto are deemed to be furnished with this Quarterly Report on Form 10-Q and will not be deemed to be “filed” for purposes of Section 18 of the Exchange Act. Such certifications will not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except to the extent that the Registrant specifically incorporates it by reference.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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VOR BIOPHARMA INC. |
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Date: May 14, 2025 |
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By: |
/s/ Robert Ang |
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Robert Ang President and Chief Executive Officer (Principal Executive Officer) |
Date: May 14, 2025 |
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By: |
/s/ Han Choi |
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Han Choi Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) |
22