UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 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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(Address of principal executive offices) |
(Zip Code) |
Registrant’s telephone number, including area code: (
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
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The |
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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.
Large accelerated filer |
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Accelerated filer |
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Smaller reporting company |
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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
The number of shares of Registrant’s Common Stock outstanding as of May 4, 2023 was
Table of Contents
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Page |
PART I |
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Item 1. |
1 |
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1 |
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Condensed Consolidated Statements of Operations and Comprehensive Loss |
2 |
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Condensed Consolidated Statements of Common Stock and Stockholders’ Equity |
3 |
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4 |
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5 |
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Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
15 |
Item 3. |
24 |
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Item 4. |
24 |
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PART II |
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Item 1. |
25 |
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Item 1A. |
25 |
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Item 2. |
63 |
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Item 3. |
64 |
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Item 4. |
64 |
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Item 5. |
64 |
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Item 6. |
64 |
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66 |
i
PART I—FINANCIAL INFORMATION
Item 1. Financial Statements (Unaudited)
SENSEI BIOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
(In thousands, except share and per share data)
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March 31, |
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December 31, |
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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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Right of use assets - operating leases, net |
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Right of use assets - financing leases, net |
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Property and equipment, net |
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Other non-current 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 and accrued liabilities |
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$ |
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$ |
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Compensation and employee benefits liabilities |
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Operating lease liabilities, current |
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Financing lease liabilities, current |
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Total current liabilities |
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Operating lease liabilities, non-current |
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Financing lease liabilities, non-current |
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Other non-current liabilities |
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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 deficit |
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( |
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( |
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Accumulated other comprehensive loss |
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( |
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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 unaudited condensed consolidated financial statements.
1
SENSEI BIOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
(In thousands, except share and per share data)
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For the Three Months Ended March 31, |
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2023 |
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2022 |
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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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Loss from operations |
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( |
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( |
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Other income (expense): |
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Interest income |
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Interest expense |
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( |
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( |
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Loss on asset disposal |
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( |
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— |
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Other income, net |
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Net loss |
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( |
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Net loss per common share, basic and diluted |
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$ |
( |
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$ |
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Weighted-average number of shares used in computing net loss per common share, basic and diluted |
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Comprehensive loss: |
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Net loss |
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$ |
( |
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$ |
( |
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Other comprehensive items: |
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Unrealized gain (loss) on marketable securities |
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( |
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Total other comprehensive income (loss) |
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( |
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Total comprehensive loss |
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$ |
( |
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$ |
( |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
2
SENSEI BIOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMMON STOCK AND STOCKHOLDERS’ EQUITY
(Unaudited)
(In thousands, except share data)
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Common Stock |
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Additional Paid-In |
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Accumulated |
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Accumulated Other |
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Total Stockholders’ |
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Shares |
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Amount |
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Capital |
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Deficit |
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Comprehensive Loss |
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Equity |
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Balance at December 31, 2021 |
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$ |
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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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Exercise of options into common stock |
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— |
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— |
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— |
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Employee stock purchase plan expense |
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— |
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— |
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— |
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— |
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Unrealized loss on marketable securities |
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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, 2022 |
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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 December 31, 2022 |
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$ |
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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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Issuance of equity in exchange for compensation |
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— |
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— |
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— |
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Surrender of shares for tax withholding |
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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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Vesting of restricted stock shares |
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— |
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— |
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— |
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— |
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— |
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Unrealized loss on marketable securities |
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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, 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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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
3
SENSEI BIOTHERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(In thousands)
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Three Months Ended March 31, |
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2023 |
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2022 |
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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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Stock-based compensation expense |
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Depreciation and amortization |
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Accretion on marketable securities |
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( |
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Non-cash lease expense |
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Amortization of financing lease right-of-use assets |
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Realized gain on marketable securities |
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— |
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( |
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Loss on fixed asset disposition |
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— |
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Gain on fixed asset disposition |
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( |
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— |
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Changes in operating assets and liabilities: |
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Prepaid expenses |
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( |
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( |
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Other assets |
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( |
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Accounts payable and accrued liabilities |
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Compensation and employee benefits |
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( |
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( |
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Operating lease liabilities |
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( |
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( |
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Other liabilities |
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( |
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Net cash used in operating activities |
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( |
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( |
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Investing activities |
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Purchases of property and equipment |
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( |
) |
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( |
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Purchases of short-term investments |
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( |
) |
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( |
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Sales of short-term investments |
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— |
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Maturities of short-term investments |
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Proceeds from sale of property and equipment |
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— |
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Net cash provided by investing activities |
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Financing activities |
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Principle payments for financing leases |
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( |
) |
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( |
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Proceeds from the exercise of common stock options |
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— |
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Payment of employee restricted stock tax withholdings |
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( |
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— |
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Employee stock purchase plan proceeds |
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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 and cash equivalents |
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( |
) |
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Cash and cash equivalents at beginning of period |
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Cash and cash equivalents at end of period |
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$ |
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$ |
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Supplemental disclosure of noncash financing information: |
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Property and equipment additions included in accounts payable and accrued liabilities |
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$ |
— |
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$ |
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Property and equipment disposals included in other assets |
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$ |
( |
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$ |
— |
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Issuance of equity in exchange for compensation included in compensation and employee benefits |
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$ |
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$ |
— |
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Initial measurement of operating lease right-of-use assets |
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$ |
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$ |
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Initial measurement of operating lease liabilities |
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$ |
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$ |
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Initial measurement of finance lease right-of-use assets |
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$ |
— |
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$ |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
4
SENSEI BIOTHERAPEUTICS, INC.
NOTES TO CONDENSED consolidated FINANCIAL STATEMENTS
(Unaudited)
1. ORGANIZATION AND OPERATIONS
Business
Sensei Biotherapeutics, Inc. (the “Company” or “Sensei”) is an immuno-oncology company that was incorporated in 1999 as a Maryland corporation until incorporated in Delaware on December 1, 2017. The Company is focused on the discovery and development of next-generation therapeutics for cancer patients.
Liquidity and capital resources
Since its inception, the Company has devoted substantially all of its resources to advancing development of its portfolio of programs, establishing and protecting its intellectual property, conducting research and development activities, organizing and staffing the Company, business planning, raising capital and providing general and administrative support for these operations. The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry including, but not limited to, technical risks associated with the successful research, development and manufacturing of product candidates, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations and the ability to secure additional capital to fund operations. Current and future programs will require significant research and development efforts, including extensive preclinical and clinical testing and regulatory approval prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel and infrastructure. Even if the Company’s drug development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales.
Since its inception, the Company has incurred substantial losses and had a net loss of $
The Company expects that its cash, cash equivalents and marketable securities as of March 31, 2023 of $
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation and Principles of Consolidation
The Company has prepared the accompanying condensed consolidated financial statements in conformity with generally accepted accounting principles in the United States (“US GAAP”). The condensed consolidated financial statements include those accounts of the Company and its subsidiaries after elimination of all intercompany accounts and transactions.
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 (“SEC”). Certain information and note disclosures normally included in financial statements prepared in accordance with US GAAP have been condensed or omitted from these condensed consolidated financial statements, as is permitted by such rules and regulations. Accordingly, these condensed consolidated financial statements should be read in conjunction with the financial statements and notes thereto included in the Company’s Annual Report on Form 10-K. The results for any interim period are not necessarily indicative of results for any future period.
5
Use of Estimates
The preparation of condensed consolidated financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, and the reported amounts of expenses during the reporting periods presented. Estimates are used for, but are not limited to, depreciation of equipment, the Company’s enterprise value, fair value of financial instruments, the Company’s ability to continue as a going concern and contingencies. Actual results may differ from those estimates.
Cash equivalents are highly liquid investments with an original maturity of 90 days or less at the date of purchase and consist of time deposits and investments in money market funds with commercial banks and financial institutions. At March 31, 2023, cash and cash equivalents included cash on deposit at commercial banks and a money market fund that invests in U.S. Government securities.
Marketable securities
Investments consist of marketable securities with original maturities greater than 90 days. The Company has classified its investments with maturities beyond one year as short-term, based on their highly liquid nature and because such marketable securities represent the investment of cash that is available for current operations. The Company considers its investment portfolio of marketable securities to be available-for-sale. Accordingly, these investments are recorded at fair value (Level 2). Unrealized gains and losses are reported as the accumulated other comprehensive items in stockholders’ equity. Amortization and accretion of premiums and discounts are recorded in other income (expense). Realized gains or losses on debt securities are included in interest income or interest expense, respectively. If any adjustment to fair value reflects a decline in value of the investment, the Company considers all available evidence to evaluate the extent to which the decline is other than temporary and, if so, marks the investment to market on the Company’s statement of operations and comprehensive loss.
Property and Equipment
Property and equipment are recorded at cost and depreciated or amortized over the estimated useful lives of the assets. Repairs or maintenance costs are expensed as incurred.
Office equipment and furniture |
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Research equipment |
Leases
Effective
Leases with a term greater than one year are recognized on the balance sheet as right-of-use assets and current and non-current lease liabilities, as applicable. The Company elected not to separate lease and non-lease components for all underlying assets. As most of the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at the commencement date in determining the present value of lease payments. The incremental borrowing rate is determined by using the rate of interest that the Company would pay to borrow on a collateralized basis an amount equal to the lease payments for a similar term and in a similar economic environment. Lease terms include options to extend or terminate the lease when it is reasonably certain that the Company will exercise the options. For leases that existed prior to the adoption of ASC 842, the Company used the remaining lease term to determine the appropriate incremental borrowing rate.
Recently Issued Accounting Standards Updates
In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. ASU 2016-13 provides guidance for estimating credit losses on certain types of financial instruments, including trade receivables, by introducing an approach based on expected losses. ASU 2016-13 also amends the
6
accounting for credit losses on available-for-sale debt securities and purchased financial assets with credit deterioration. The guidance requires a modified retrospective transition method and early adoption is permitted. In November 2019, FASB issued ASU No. 2019-10, Financial Instruments – Credit Losses, Derivatives and Hedging, and Leases (“ASU 2019-10”), which defers the adoption of ASU 2016-13 for smaller reporting companies until periods beginning after December 15, 2022. The Company has
3. MARKETABLE SECURITIES
Marketable securities consist of the following as of March 31, 2023 (in thousands):
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Amortized Cost |
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Unrealized Gains |
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Unrealized Losses |
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Fair Value |
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Commercial paper |
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$ |
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$ |
- |
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$ |
( |
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$ |
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Corporate bonds |
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- |
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( |
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U.S. Government agencies |
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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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As of March 31, 2023, all marketable securities held by the Company had remaining contractual maturities of
As of March 31, 2023, $
There were
4. PROPERTY AND EQUIPMENT, NET
Property and equipment, net consist of the following (in thousands):
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March 31, |
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December 31, |
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Research equipment |
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$ |
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$ |
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Office equipment and furniture |
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Leasehold improvement |
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Total property and equipment |
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Less accumulated depreciation and amortization |
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( |
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( |
) |
Property and equipment, net |
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$ |
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$ |
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Depreciation and amortization expense for the three months ended March 31, 2023 and 2022 was $
Effective January 1, 2022, the Company adopted ASC 842 and reclassed capital leases that were previously classified as property and equipment, net were presented separately under right of use assets - financing leases, net on the Company's condensed consolidated balance sheet. $
7
5. FAIR VALUE MEASUREMENTS
The following tables present information about the Company’s financial assets and liabilities measured at fair value on a recurring basis and indicate the level of the fair value hierarchy used to determine such fair values (in thousands):
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Fair value measurements at March 31, 2023 |
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Level 1 |
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Level 2 |
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Level 3 |
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Total |
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Assets: |
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Cash equivalents |
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Money market funds |
|
$ |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
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||
Investments: |
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Commercial paper |
|
|
- |
|
|
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|
|
|
- |
|
|
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||
Corporate bonds |
|
|
- |
|
|
|
|
|
|
- |
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|
|
|
||
U.S. Government agencies |
|
|
- |
|
|
|
|
|
|
- |
|
|
|
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||
Total |
|
$ |
|
|
$ |
|
|
$ |
- |
|
|
$ |
|
When developing fair value estimates, the Company maximizes the use of observable inputs and minimizes the use of unobservable inputs. When available, the Company uses quoted market prices to measure fair value. The valuation technique used to measure fair value for the Company's Level 1 and Level 2 assets is a market approach, using prices and other relevant information generated by market transactions involving identical or comparable assets. If market prices are
There were
6
Operating Leases
As of March 31, 2023, the Company leases office and laboratory facilities under operating leases, which expire at various dates through
The Company entered into an operating sublease agreement on January 18, 2023 (the "Sublease") with respect to part of its existing Boston office and laboratory facilities (the "Head Lease"). The Company accounted for the Head Lease and the Sublease as separate contracts and there was no effect on the right-of-use asset or lease liability associated with the Head Lease. The Sublease is long-term and has an effective end date of more than one year from March 31, 2023. The Head Lease rent expense is presented separately from income related to the Sublease and both are reported as components of operating expenses on the condensed consolidated statements of operations and comprehensive loss. The Company recorded $
Finance Leases
The Company leases research equipment and furniture under finance leases.
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Three Months Ended March 31, |
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2023 |
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Lease Cost: |
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|
|
|
Amortization of finance right-of-use assets |
|
$ |
|
|
Interest on finance lease liabilities |
|
|
|
|
Operating lease cost |
|
|
|
|
Variable lease cost |
|
|
|
|
Total lease costs |
|
$ |
|
|
Operating Sublease income |
|
|
( |
) |
Total lease costs, net |
|
$ |
|
The following table contains a summary of other information pertaining to the Company’s finance and operating leases for the three months ended March 31, 2023 (in thousands, except lease term and discount rate):
8
|
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Three Months Ended March 31, |
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2023 |
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