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)
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(State or other jurisdiction of incorporation or organization) |
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(I.R.S. Employer Identification No.) |
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(Address of principal executive offices) |
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(Zip Code) |
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(Registrant’s telephone number, including area code)
Not Applicable
(Former name, former address and former fiscal year, if changed since last report)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
(Nasdaq Global Select Market) |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
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, a 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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☒ |
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Non-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. ☐
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Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No |
As of October 31, 2023, the registrant had
Seres Therapeutics, Inc.
INDEX
2
FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q, or the Quarterly Report, contains forward-looking statements. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this Quarterly Report, including without limitation statements regarding our future results of operations and financial position, business strategy, prospective products, product approvals, research and development costs, timing and likelihood of success, manufacturing activities and related timing, timing, execution, and expected benefits of our restructuring initiative and cost saving measures, commercialization efforts and related timing, plans and objectives of management for future operations and future results of anticipated products, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.
In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this Quarterly Report are only predictions. 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 speak only as of the date of this report and are subject to a number of important factors that could cause actual results to differ materially from those in the forward-looking statements, including the risks, uncertainties and assumptions described under the sections in this report titled “Summary Risk Factors,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in this Quarterly Report.
Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties.
You should read this Quarterly Report and the documents that we reference in this Quarterly Report completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
TRADEMARKS, SERVICE MARKS AND TRADENAMES
We have proprietary rights to trademarks used in this Quarterly Report, which are important to our business and many of which are registered under applicable intellectual property laws. Solely for convenience, the trademarks, service marks, logos and trade names referred to in this Quarterly Report are without the ® and ™ symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights to these trademarks, service marks and trade names. This Quarterly Report contains additional trademarks, service marks and trade names of others, which are the property of their respective owners. All trademarks, service marks and trade names appearing in this Quarterly Report are, to our knowledge, the property of their respective owners. We do not intend our use or display of other companies’ trademarks, service marks, copyrights or trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.
SUMMARY RISK FACTORS
Our business is subject to numerous risks and uncertainties, including those described in Part II, Item 1A. “Risk Factors” in this Quarterly Report. You should carefully consider these risks and uncertainties when investing in our common stock. The principal risks and uncertainties affecting our business include the following:
3
4
PART I – FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements (unaudited)
SERES THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited, in thousands, except share and per share data)
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September 30, |
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December 31, |
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2023 |
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2022 |
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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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Short term investments |
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Collaboration receivable - related party |
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Inventories |
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Prepaid expenses and other current assets |
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Total current assets |
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Property and equipment, net |
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Operating lease assets |
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Restricted cash |
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Restricted investments |
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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’ (Deficit) 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 expenses and other current liabilities (1) |
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Operating lease liabilities |
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Short term portion of note payable, net of discount |
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Deferred income - related party |
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Deferred revenue - related party |
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Total current liabilities |
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Long term portion of note payable, net of discount |
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Operating lease liabilities, net of current portion |
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Deferred revenue, net of current portion - related party |
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Warrant liabilities |
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Other long-term liabilities |
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Total liabilities |
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Stockholders’ (deficit) 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 loss |
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( |
) |
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Accumulated deficit |
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( |
) |
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( |
) |
Total stockholders’ (deficit) equity |
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( |
) |
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Total liabilities and stockholders’ (deficit) equity |
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$ |
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$ |
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[1]
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
5
SERES THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(unaudited, in thousands, except share and per share data)
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Three Months Ended |
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Nine Months Ended |
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2023 |
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2022 |
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2023 |
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2022 |
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Revenue: |
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- related party |
$ |
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$ |
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$ |
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$ |
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Total revenue |
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$ |
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Operating expenses: |
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Research and development expenses |
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$ |
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General and administrative expenses |
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$ |
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Collaboration (profit) loss sharing - related party |
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( |
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$ |
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Total operating expenses |
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$ |
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Loss from operations |
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( |
) |
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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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$ |
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Interest expense |
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( |
) |
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( |
) |
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$ |
( |
) |
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( |
) |
Other income (expense) |
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( |
) |
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$ |
( |
) |
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( |
) |
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Total other expense, net |
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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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$ |
( |
) |
Net loss per share attributable to common stockholders, basic and diluted |
$ |
( |
) |
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$ |
( |
) |
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$ |
( |
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$ |
( |
) |
Weighted average common shares outstanding, basic and diluted |
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$ |
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Other comprehensive income (loss): |
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Unrealized gain (loss) on investments, net of tax of $ |
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( |
) |
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Currency translation adjustment |
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( |
) |
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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 unaudited condensed consolidated financial statements.
6
SERES THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ (DEFICIT) EQUITY
(unaudited, in thousands, except share data)
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Common Stock |
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Additional |
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Accumulated |
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Total |
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Shares |
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Par |
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Paid-in |
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Accumulated |
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Comprehensive |
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Stockholders’ |
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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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||||
Issuance of common stock upon exercise of stock options |
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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 tax withholdings |
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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 under ESPP |
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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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( |
) |
Net loss |
|
|
— |
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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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||||
Issuance of common stock upon exercise of stock options |
|
|
|
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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 tax withholdings |
|
|
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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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Other comprehensive loss |
|
|
— |
|
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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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( |
) |
Balance at June 30, 2022 |
|
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$ |
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$ |
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$ |
( |
) |
|
$ |
( |
) |
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$ |
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||||
Issuance of common stock net of issuance costs of $ |
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||||||
Issuance of common stock upon exercise of stock options |
|
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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 tax withholdings |
|
|
|
|
|
— |
|
|
|
— |
|
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|
— |
|
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|
— |
|
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|
— |
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|
Issuance of common stock under ESPP |
|
|
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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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Other comprehensive income |
|
|
— |
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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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( |
) |
Balance at September 30, 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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7
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Common Stock |
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Additional |
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Accumulated |
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Total |
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Shares |
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Par |
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Paid-in |
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Accumulated |
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Comprehensive |
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Stockholders’ |
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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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||||
Issuance of common stock upon exercise of stock options |
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— |
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— |
|
|
|
— |
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|||
Issuance of common stock upon vesting of RSUs, net of tax withholdings |
|
|
|
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|
— |
|
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|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
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|
Issuance of common stock under ESPP |
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|
|
|
|
— |
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|
— |
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||||
Issuance of common stock from at the market equity offering, net of issuance costs of $ |
|
|
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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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||
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
Balance at March 31, 2023 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|
$ |
( |
) |
||||
Issuance of common stock upon exercise of stock options |
|
|
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|
|
— |
|
|
|
|
|
|
— |
|
|
|
— |
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|||
Issuance of common stock upon vesting of RSUs and PSUs, net of tax withholdings |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Issuance of common stock from at the market equity offering, net of issuance costs of $ |
|
|
|
|
|
|
|
|
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|
|
— |
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|
— |
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||||
Issuance of warrants (Note 9) |
|
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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 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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( |
) |
Net income |
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— |
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— |
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— |
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— |
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||
Balance at June 30, 2023 |
|
|
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|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
||||
Issuance of common stock upon exercise of stock options |
|
|
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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 tax withholdings |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Issuance of common stock under ESPP |
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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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