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 | (I.R.S. Employer |
(Address of principal executive offices) | (Zip Code) |
(
(Registrant’s telephone number, including area code)
N/A
(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 | ||
|
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☐
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 ☐ | Accelerated filer ☐ |
Smaller reporting company | |
Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes
The number of shares of the registrant’s Series A common stock, $0.0001 par value per share, outstanding at August 16, 2023 was
Table of Contents
PART I - FINANCIAL INFORMATION |
| Page | |
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8 | |||
Condensed Statements of Redeemable Convertible Preferred Stock and Stockholders’ Deficit | 9 | ||
10 | |||
11 | |||
Management’s Discussion and Analysis of Financial Condition and Results of Operations | 26 | ||
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36 | |||
36 | |||
83 | |||
84 | |||
84 | |||
84 | |||
87 | |||
89 |
2
FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q (this Quarterly Report) contains forward-looking statements about us and our industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this Quarterly Report, including statements regarding our future results of operations and financial position, business strategy, drug candidates, planned preclinical studies and clinical trials, results of preclinical studies, clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, as well as plans and objectives of management for future operations, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that are in some cases beyond our control and 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,” “would,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “believe,” “estimate,” “predict,” “potential,” or “continue” or the negative of these terms or other similar expressions. Forward-looking statements contained in this Quarterly Report include, but are not limited to, statements about:
● | our financial performance; |
● | our ability to obtain additional cash and the sufficiency of our existing cash, cash equivalents and short-term investments in marketable securities to fund our future operating expenses and capital expenditure requirements; |
● | the accuracy of our estimates regarding expenses, future revenue, capital requirements, and needs for additional financing; |
● | the scope, progress, results and costs of developing denifanstat or any other drug candidates we may develop, and conducting preclinical studies and clinical trials, including our FASCINATE-2 Phase 2b clinical trial; |
● | the timing and costs involved in obtaining and maintaining regulatory approval of denifanstat or any other drug candidates we may develop, and the timing or likelihood of regulatory filings and approvals, including our expectation to seek special designations or accelerated approvals for our drug candidates for various indications; |
● | current and future agreements with third parties in connection with the development and commercialization of denifanstat or any other future drug candidate; |
● | our estimated number of patients in the United States who suffer from the diseases we target, including nonalcoholic steatohepatitis (NASH), and the number of subjects that will enroll in our clinical trials; |
● | our ability to advance drug candidates into and successfully complete clinical trials; |
● | our relationship with Ascletis BioScience Co. Ltd. (Ascletis), and its affiliate Gannex Pharma Co., Ltd. (Gannex), and the success of their development efforts for denifanstat; |
● | the ability of our clinical trials to demonstrate the safety and efficacy of denifanstat and any other drug candidates we may develop, and other positive results; |
● | our plans relating to commercializing denifanstat and any other drug candidates we may develop, if approved, including the geographic areas of focus and our ability to grow a sales team; |
● | the success of competing therapies that are or may become available; |
● | developments relating to our competitors and our industry, including competing drug candidates and therapies; |
3
● | our plans relating to the further development and manufacturing of denifanstat and any other drug candidates we may develop, including additional indications that we may pursue for denifanstat or other drug candidates; |
● | existing regulations and regulatory developments in the United States and other jurisdictions; |
● | our potential and ability to successfully manufacture and supply denifanstat and any other drug candidates we may develop for clinical trials and for commercial use, if approved; |
● | the rate and degree of market acceptance of denifanstat and any other drug candidates we may develop, as well as the pricing and reimbursement of denifanstat and any other drug candidates we may develop, if approved; |
● | our expectations regarding our ability to obtain, maintain, protect and enforce intellectual property protection for denifanstat and for any other future drug candidate; |
● | our ability to attract and retain the continued service of our key personnel and to identify, hire, and then retain additional qualified personnel and our ability to attract additional collaborators with development, regulatory and commercialization expertise; |
● | the impact of the COVID-19 pandemic on our business and operations, including enrollment in our clinical trials, manufacturing suppliers, collaborators, use of CROs and employees; |
● | our expectations regarding the period during which we will qualify as an emerging growth company under the JOBS Act; and |
● | our anticipated use of our existing cash, cash equivalents and short-term investments in marketable securities. |
We have based these forward-looking statements largely on our current expectations and projections about our business, the industry in which we operate and financial trends that we believe may affect our business, financial condition, results of operations and prospects, and these forward-looking statements are not guarantees of future performance or development. These forward-looking statements speak only as of the date of this Quarterly Report and are subject to a number of risks, uncertainties and assumptions described in Part II, Item 1A. “Risk Factors” and elsewhere in this Quarterly Report. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein until after we distribute this Quarterly Report, whether as a result of any new information, future events or otherwise.
In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Quarterly Report, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and you are cautioned not to unduly rely upon these statements.
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 on Form 10-Q. You should carefully consider these risks and uncertainties when investing in our Series A common stock. The principal risks and uncertainties affecting our business include the following:
● | We will require substantial additional capital to finance our operations. If we are unable to raise such capital when needed, or on acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of our research and drug development programs or future commercialization efforts. |
4
● | Currently our business depends on the success of our lead drug candidate, denifanstat, which is still in clinical development. If we are unable to obtain regulatory approval for or successfully commercialize denifanstat, our business will be materially harmed. |
● | Clinical drug development involves a lengthy and expensive process, with an uncertain outcome. If clinical trials or regulatory approval processes for our drug candidates are prolonged, delayed or suspended, we may be unable to seek regulatory approval for and commercialize our drug candidates on a timely basis, which would require us to incur additional costs and delay our receipt of any revenue from potential product sales. |
● | We may not be successful in our efforts to expand our pipeline, including by identifying additional indications for which to investigate denifanstat in the future. We may expend our limited resources to pursue a particular indication or formulation for denifanstat and fail to capitalize on drug candidates, indications or formulations that may be more profitable or for which there is a greater likelihood of success. |
● | Interim, top-line and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data. |
● | We have licensed rights to denifanstat to Ascletis, a significant stockholder, for a territory that we refer to as “Greater China”, and Ascletis has assigned the license to its affiliate Gannex. Under the license agreement, Ascletis controls certain product development efforts in its territory, including conduct of clinical trials, which could have an impact on our clinical development programs. |
● | We may attempt to seek approval from the FDA or comparable foreign regulatory authorities through the use of accelerated approval pathways. If we are unable to obtain such approval, we may be required to conduct additional clinical trials beyond those that we contemplate, which could increase the expense of obtaining, and delay the receipt of, necessary marketing approvals. Even if we receive accelerated approval from the FDA, or similar foreign approvals from foreign regulatory authorities, if our confirmatory trials do not verify clinical benefit, or if we do not comply with rigorous post-marketing requirements, the FDA or comparable foreign regulatory authorities may seek to withdraw any accelerated approval or similar foreign approval we have obtained. |
● | If we are unable to obtain, maintain and enforce sufficient patent protection for our drug candidates, or if the scope of the patent protection is not sufficiently broad, third parties, including our competitors, could develop and commercialize products similar or identical to ours, and our ability to commercialize our drug candidates successfully may be adversely affected. We have relied on, and we expect to continue to rely on, third-party manufacturers to produce our drug candidates. Our manufacturers may experience manufacturing difficulties due to the ongoing effects of inflationary pressures, resource constraints, labor disputes or unstable political environments, which could delay the completion of our clinical trials, increase the costs associated with maintaining clinical trial programs and, significantly impact our ability to develop, obtain regulatory approval for, or market denifanstat and any future drug candidates. |
● | Our quarterly operating results may fluctuate significantly or may fall below the expectations of investors or securities analysts, each of which may cause our stock price to fluctuate or decline. |
● | Our principal stockholders and management own a significant percentage of our common stock and will be able to exert significant control over matters subject to stockholder approval. |
● | The COVID-19 pandemic, or a similar pandemic, epidemic or outbreak of an infectious disease, may materially and adversely affect our business and our financial results and could cause a disruption to the development of our drug candidates. |
5
● | Unfavorable global political or economic conditions or adverse developments affecting the financial services industry could adversely affect our current and projected business operations, financial condition and results of operations. |
● | Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware and, to the extent enforceable, the federal district courts of the United States of America will be the exclusive forums for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, or employees. |
TRADEMARKS, TRADE NAMES AND SERVICE MARKS
This Quarterly Report includes our trademarks, trade names and service marks, including, without limitation, “SGMT” and our logo, which are our property and are protected under applicable intellectual property laws. Solely for convenience, trademarks, trade names and service marks may appear in this Quarterly Report without the ®, TM and SM symbols, but such references are not intended to indicate, in any way, that we or the applicable owner forgo or will not assert, to the fullest extent permitted under applicable law, our rights or the rights of any applicable licensors to these trademarks, trade names and service marks. We do not intend our use or display of other parties’ trademarks, trade names or service marks to imply, and such use or display should not be construed to imply a relationship with, or endorsement or sponsorship of us by, these other parties.
INDUSTRY AND OTHER DATA
Unless otherwise indicated, information contained in this Quarterly Report concerning our industry and the markets in which we operate, including our general expectations, market position and market opportunity, is based on our management’s estimates and research, as well as industry and general publications and research, surveys and studies conducted by third parties. We believe the information from these third-party publications, research, surveys and studies included in this Quarterly Report is reliable. Management’s estimates are derived from publicly available information, their knowledge of our industry and their assumptions based on such information and knowledge, which we believe to be reasonable. This data involves a number of assumptions and limitations which are necessarily subject to a high degree of uncertainty and risk due to a variety of factors, including those described in this Quarterly Report under “Forward-Looking Statements” and Part II, Item 1A “Risk Factors.” These and other factors could cause our future performance to differ materially from our assumptions and estimates.
6
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements (Unaudited)
SAGIMET BIOSCIENCES INC.
CONDENSED BALANCE SHEETS
(Unaudited)
(in thousands, except for share and per share amounts)
As of | As of | |||||
June 30, | December 31, | |||||
| 2023 |
| 2022 | |||
Assets | ||||||
Current assets: |
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Cash and cash equivalents | $ | | $ | | ||
Short-term investments in marketable securities |
| — |
| | ||
Prepaid expenses and other current assets | | | ||||
Total current assets | | | ||||
Operating lease right-of-use assets | | | ||||
Deposits |
| — |
| | ||
Total assets | $ | | $ | | ||
Liabilities, redeemable convertible preferred stock and stockholders’ deficit |
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Current liabilities: |
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Accounts payable | $ | | $ | | ||
Accrued expenses and other current liabilities |
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Operating lease liabilities |
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Total current liabilities |
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Long-term liabilities |
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Operating lease liabilities, less current portion |
| — |
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Redeemable convertible preferred stock warrant liability |
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Total liabilities |
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Commitments and contingencies (Note 7) |
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Redeemable convertible preferred stock: $ |
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Stockholders’ deficit: |
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Common stock, $ |
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Additional paid-in capital |
| |
| | ||
Accumulated other comprehensive loss |
| — |
| ( | ||
Accumulated deficit |
| ( |
| ( | ||
Total stockholders’ deficit |
| ( |
| ( | ||
Total liabilities, redeemable convertible preferred stock and stockholders’ deficit | $ | | $ | |
The accompanying notes are an integral part of these unaudited condensed financial statements.
7
SAGIMET BIOSCIENCES INC.
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
(in thousands, except for share and per share amounts)
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||
2023 |
| 2022 |
| 2023 |
| 2022 | ||||||
Operating expenses: |
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Research and development | $ | | $ | | $ | | $ | | ||||
General and administrative |
| |
| |
| |
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Total operating expenses |
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Loss from operations |
| ( |
| ( |
| ( |
| ( | ||||
Other income (expense), net: |
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Change in fair value of redeemable convertible preferred stock warrants |
| |
| — |
| ( |
| | ||||
Interest income and other |
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Total other income, net |
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Net loss | $ | ( | $ | ( | $ | ( | $ | ( | ||||
Other comprehensive gain (loss): |
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Net unrealized gain (loss) on investments in marketable securities |
| |
| ( |
| |
| ( | ||||
Total other comprehensive gain (loss) |
| |
| ( |
| |
| ( | ||||
Comprehensive loss | $ | ( | $ | ( | $ | ( | $ | ( | ||||
Net loss per share attributable to common stockholders, basic and diluted | $ | ( | $ | ( | $ | ( | $ | ( | ||||
Weighted-average shares outstanding used in computing net loss per share attributable to common stockholders, basic and diluted |
| |
| |
| |
| |
The accompanying notes are an integral part of these unaudited condensed financial statements.
8
SAGIMET BIOSCIENCES INC.
CONDENSED STATEMENTS OF REDEEMABLE CONVERTIBLE PREFERRED STOCK AND
STOCKHOLDERS’ DEFICIT
(Unaudited)
(in thousands, except share amounts)
Accumulated | |||||||||||||||||||||||||
| Redeemable convertible | Additional | Other | Total | |||||||||||||||||||||
Preferred Stock |
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| Common Stock | Paid-in | Accumulated | Comprehensive | Stockholders’ | ||||||||||||||||||
| Shares |
| Amount |
|
| Shares |
| Amount |
| Capital |
| Deficit |
| (Loss) Income |
| Deficit | |||||||||
Balance at January 1, 2023 |
| |
| $ | |
| |
| $ | |
| $ | |
| $ | ( |
| $ | ( |
| $ | ( | |||
Net loss |
| — |
| — |
| — |
| — |
| — |
| ( |
| — |
| ( | |||||||||
Unrealized gain on investments in marketable securities |
| — |
| — |
| — |
| — |
| — |
| — |
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Stock-based compensation expense |
| — |
| — |
| — |
| — |
| |
| — |
| — |
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Balance at March 31, 2023 |
| | $ | |
| | $ | | $ | | $ | ( | $ | ( | $ | ( | |||||||||
Net loss |
| — |
| — |
| — |
| — |
| — |
| ( |
| — |
| ( | |||||||||
Exercise of common stock warrants | — | — | | — | — | — | — | — | |||||||||||||||||
Unrealized gain on investments in marketable securities |
| — |
| — |
| — |
| — |
| — |
| — |
| |
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Stock-based compensation expense |
| — |
| — |
| — |
| — |
| |
| — |
| — |
| | |||||||||
Balance at June 30, 2023 |
| | $ | |
| | $ | | $ | | $ | ( | $ | — | $ | ( | |||||||||
Accumulated | |||||||||||||||||||||||||
Redeemable convertible | Additional | Other | Total | ||||||||||||||||||||||
Preferred Stock |
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| Common Stock | Paid-in | Accumulated | Comprehensive | Stockholders’ | ||||||||||||||||||
Shares |
| Amount |
|
| Shares |
| Amount |
| Capital |
| Deficit |
| Loss |
| Deficit | ||||||||||
Balance at January 1, 2022 |
| | $ | |
| | $ | | $ | | $ | ( | $ | — | $ | ( | |||||||||
Net loss |
| — |
| — |
| — |
| — |
| — |
| ( |
| — | ( | ||||||||||
Exercise of stock options |
| — |
| — |
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| — |
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| — |
| — |
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Stock-based compensation expense |
| — |
| — |
| — |
| — |
| |
| — |
| — |
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Balance at March 31, 2022 |
| | $ | |
| | $ | | $ | | $ | ( | $ | — | $ | ( | |||||||||
Net loss |
| — |
| — |
| — |
| — |
| — |
| ( |
| — | ( | ||||||||||
Unrealized loss on investments in marketable securities |
| — |
| — |
| — |
| — |
| — |
| — |
| ( |
| ( | |||||||||
Stock-based compensation expense |
| — |
| — |
| — |
| — |
| |
| — |
| — |
| | |||||||||
Balance at June 30, 2022 |
| | $ | |
| | $ | | $ | | $ | ( | $ | ( | $ | ( |
The accompanying notes are an integral part of these unaudited condensed financial statements.
9
SAGIMET BIOSCIENCES INC.
CONDENSED STATEMENTS OF CASH FLOWS
(Unaudited)
(in thousands)
Six Months Ended June 30, | ||||||
2023 | 2022 | |||||
Cash flows from operating activities: |
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Net loss | $ | ( | $ | ( | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
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Accretion of discount on marketable securities, net |
| ( |
| ( | ||
Non-cash lease expense |
| |
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Stock-based compensation expense |
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Change in fair value of redeemable convertible preferred stock warrants |
| |
| ( | ||
Changes in operating assets and liabilities: |
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Prepaid expenses and other current assets |
| |
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Accounts payable and accrued liabilities |
| ( |
| | ||
Operating lease liabilities |
| ( |
| ( | ||
Net cash used in operating activities |
| ( |
| ( | ||
Cash flows from investing activities: |
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Purchases of marketable securities | — | ( | ||||
Sales of marketable securities |
| |
| — | ||
Net cash provided (used in) by investing activities |
| |
| ( | ||
Cash flows from financing activities: |
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Payment of deferred financing costs | ( | ( | ||||
Proceeds from exercise of stock options |
| — |
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Net cash used in financing activities |
| ( |
| ( | ||
Net increase (decrease) in cash and cash equivalents |
| |
| ( | ||
Cash and cash equivalents at beginning of period |
| |
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Cash and cash equivalents at end of period | $ | | $ | | ||
Supplemental cash flow information |
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Unpaid deferred financing costs included in accounts payable and accrued expenses | $ | | $ | — |
The accompanying notes are an integral part of these unaudited condensed financial statements.
10
SAGIMET BIOSCIENCES INC.
NOTES TO THE UNAUDITED CONDENSED FINANCIAL STATEMENTS
1. | Organization and description of business |
Overview
Sagimet Biosciences Inc. (the Company) was incorporated in Delaware on December 19, 2006, as 3-V Biosciences, Inc. and is headquartered in San Mateo, California. The Company changed its name from 3-V Biosciences, Inc. to Sagimet Biosciences Inc. in August 2019. The Company is a clinical-stage biopharmaceutical company developing novel therapeutics called fatty acid synthase (FASN) inhibitors that target dysfunctional metabolic pathways in diseases resulting from the overproduction of the fatty acid, palmitate.
Risks, uncertainties and going concern
The Company is subject to certain risks and uncertainties, including, but not limited to changes in any of the following areas that the Company believes could have a material adverse effect on future financial position or results of operations: the availability of future financing; the ability to obtain regulatory approval and market acceptance of, and reimbursement for, the Company’s drug candidates if approved; the performance of third-party clinical research organizations and manufacturers; protection of the intellectual property; litigation or claims against the Company based on intellectual property, patent, product, regulatory or other factors; and the Company’s ability to attract and retain employees necessary to support commercial success. In addition, significant changes in the biotechnology industry or the approval of competitive products or therapies could adversely affect the Company’s development and operating results.
As of June 30, 2023, the Company has relied on public and private equity and debt financings to fund its operations. The Company has incurred net losses and negative cash flows from operations since inception, including net losses of $
The Company will require substantial additional capital to fund its research and development and ongoing operating expenses. On July 18, 2023, the Company closed on its initial public offering (IPO), in which it issued and sold
As of August 21, 2023, the issuance date of these unaudited condensed financial statements, the Company expects that its cash and cash equivalents as of June 30, 2023, and total net proceeds from the IPO of $
11
Reverse stock split
A one-for-
reverse stock split of the Company’s issued and outstanding common stock was effected on July 7, 2023. Stockholders entitled to fractional shares as a result of the reverse stock split received a cash payment in lieu of receiving fractional shares. Accordingly, all share and per share amounts for all periods presented in the accompanying financial statements and notes thereto have been retroactively adjusted, where applicable, to reflect the effects of the reverse stock split. Shares of common stock underlying outstanding stock options and common stock warrants were proportionately reduced and the respective exercise prices, if applicable, were proportionately increased in accordance with the terms of the agreements governing such securities. Shares of common stock reserved for issuance upon the conversion of the Company’s preferred stock were proportionately reduced and the respective conversion prices were proportionately increased. See Note 13.Impact of COVID-19 pandemic on financial statements
The 2019 novel coronavirus disease (COVID-19) and the related responses by public health and governmental authorities to contain and combat its outbreak and spread severely impacted the U.S. and world economies during the end of the first quarter of 2020 through the end of 2022. Moving forward, economic recessions, increased inflation and/or interest rates, including those brought on by the continued effects of the COVID-19 outbreak may have a negative effect on the Company’s operating results. Any prolonged disruption to the Company’s operations or workforce availability is likely to have a significant adverse effect on the Company’s results of operations and cash flows. All of the above may be exacerbated in the future as the COVID-19 outbreak and the governmental responses thereto continue.
Unaudited interim financial information
The accompanying condensed balance sheet as of June 30, 2023, the condensed statements of operations and comprehensive loss for the three and six months ended June 30, 2023 and 2022, the condensed statements of redeemable convertible preferred stock and stockholders’ deficit for the three and six months ended June 30, 2023 and 2022, the condensed statements of cash flows for the six months ended June 30, 2023 and 2022, and the related disclosures are unaudited. These unaudited condensed financial statements include all adjustments necessary, consisting of only normal recurring adjustments, to fairly state the financial position and the results of the Company’s operations and cash flows for interim periods in accordance with accounting principles generally accepted in the United States of America (GAAP). Interim period results are not necessarily indicative of results of operations or cash flows for a full year or any subsequent interim period. The condensed balance sheet as of December 31, 2022 has been derived from the audited financial statements of the Company. The accompanying unaudited condensed financial statements should be read in conjunction with the Company’s audited financial statements included in the final prospectus filed pursuant to Rule 424(b)(4) under the Securities Act with the Securities and Exchange Commission (SEC) on July 17, 2023.
2. | Summary of significant accounting policies |
Basis of presentation
The financial statements and accompanying notes have been prepared in accordance with GAAP and the requirements of the SEC for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by GAAP can be condensed or omitted. These condensed financial statements have been prepared on the same basis as the annual financial statements included in the final prospectus filed pursuant to Rule 424(b)(4) under the Securities Act with the SEC on July 17, 2023.
In the Company’s opinion, the information furnished in these condensed financial statements reflects all adjustments, all of which are of a normal and recurring nature necessary for a fair presentation of the financial position and results of operations for the reported interim periods. The Company considers events or transactions that occur after the balance sheet date but before the financial statements are issued to provide additional evidence relative to certain estimates or to identify matters that require additional disclosure. 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.
12
Use of Estimates
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities as of the date of the financial statements and reported amounts of expenses during the reporting period. Such estimates include accruals of research and development expenses, accrued costs for services rendered in connection with third-party contractor clinical trial activities, preferred stock, common stock and stock option valuations and stock-based compensation. On an ongoing basis, the Company evaluates its estimates and judgments, which are based on historical and anticipated results and trends and on various other assumptions that management believes to be reasonable under the circumstances. Actual results could differ from those estimates.
Significant Accounting Policies
The Company’s significant accounting policies are disclosed in the audited financial statements for the year ended December 31, 2022, and the unaudited financial statements as of March 31, 2023, filed with the SEC as part of the final prospectus filed pursuant to Rule 424(b)(4) under the Securities Act with the SEC on July 17, 2023. Since the date of those financial statements, there have been no changes to the Company’s significant accounting policies except as disclosed below in recently adopted accounting pronouncements.
Marketable securities
The Company classifies its marketable debt securities as available-for-sale and records such assets at estimated fair value in the balance sheets. The Company adopted Accounting Standards Update (ASU) No. 2016-13, Financial Instruments — Credit Losses (Topic 326): Measurement of Credit Losses of Financial Instruments on January 1, 2023. Marketable debt securities for which the estimated fair value is below amortized cost are evaluated for credit impairment. Credit impairment is recorded through the unaudited condensed statements of operations via an allowance for credit losses account, and any remaining unrealized gains and losses are reported as a component of other comprehensive income (loss) within the unaudited condensed statements of operations and comprehensive loss and as a separate component of stockholders’ deficit. The Company classifies marketable securities with remaining maturities greater than three months but less than one year as short-term investments, and those with remaining maturities greater than one year are classified as long-term investments. For all marketable securities which the estimated fair value was below amortized cost as of December 31, 2022, the decline in fair value was not driven by credit impairment.
The Company had
Deferred financing costs
Deferred financing costs, consisting of legal, accounting and other fees and costs relating to the Company’s IPO are capitalized and recorded on the balance sheets. The deferred financing costs will be offset against the proceeds received upon the closing of the IPO. As of June 30, 2023, there were $
On March 21, 2022, the Company withdrew its prior Registration Statement on Form S-1 initially filed with the SEC on April 16, 2021. Concurrently, all of the deferred financing costs of $
Revenue recognition
The Company enters into collaboration and licensing arrangements that generally contain multiple elements or deliverables, which may include (1) licenses to the Company’s technology, (2) research and development activities performed for the collaboration partner, (3) participation on joint steering committees (JSCs), and (4) the manufacturing of clinical or preclinical material. Payments pursuant to these arrangements include milestone payments upon achieving significant development events, research and development reimbursements, sales milestones, and royalties on future drug sales. Variable consideration is constrained until it is probable that the revenue is not at a significant risk of reversal in a future period.
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In determining the appropriate amount of revenue to be recognized for the components of the arrangements that are within the scope of Accounting Standards Codification, Topic 606, Revenue from Contracts with Customers (ASC 606), the Company performs the following steps: (i) identification of the promised goods or services in the contract within the scope of ASC 606; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. As part of the accounting for these arrangements, the Company must use significant judgment to determine: a) the number of performance obligations based on the determination under step (ii) above; b) the transaction price under step (iii) above; c) the stand-alone selling price for each performance obligation identified in the contract for the allocation of transaction price in step (iv) above; and d) the measure of progress in step (v) above. The Company uses judgment to determine whether milestones or other variable consideration, except for royalties, should be included in the transaction price as described further below.
At the inception of each arrangement that includes milestone payments, the Company evaluates whether the milestones are considered probable of being achieved and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. At the end of each subsequent reporting period, the Company reevaluates the probability of achievement of all milestones subject to constraint and, if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenues and earnings in the period of adjustment.
For arrangements that include sales-based royalties or milestone payments, for which the license is deemed to be the predominant item, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).
In January 2022, Ascletis BioScience Co. Ltd. (Ascletis) initiated dosing of a Phase 3 trial for recurrent glioblastoma multiforme (GBM), potentially triggering a $
The Company and Ascletis concluded their discussions regarding the payment of the milestone in July 2023. The Company invoiced Ascletis for the milestone payment, with payment due before the end of August 2023. See Note 13.
Emerging growth company status
The Company is an emerging growth company (EGC) as defined in the Jumpstart Our Business Startups Acts of 2012, as amended (the JOBS Act), and may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not EGCs. The Company may take advantage of these exemptions until it is no longer an EGC under Section 107 of the JOBS Act and has elected to use the extended transition period for complying with new or revised accounting standards. As a result of this election, the Company’s financial statements may not be comparable to companies that comply with public company Financial Accounting Standards Board (FASB) standards’ effective dates.
Recently adopted accounting pronouncements
In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses of Financial Instruments, which, together with subsequent amendments, amends the requirement on the measurement and recognition of expected credit losses for financial assets held. ASU 2016-13 is effective for the Company for the annual periods beginning after December 15, 2022, including interim periods within those fiscal years, with early adoption permitted. The Company adopted ASU 2016-13 on January 1, 2023, using the modified retrospective approach, and no cumulative effect adjustment to accumulated deficit was needed as of the adoption date.
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New accounting pronouncements not yet adopted
In August 2020, the FASB issued ASU No. 2020-06, Debt-Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40); Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, which address issues identified as a result of the complexity associated with applying GAAP for certain financial instruments with characteristics of liabilities and equity. This amendment is effective for fiscal years beginning after December 15, 2023. The Company is currently evaluating the potential impact on its financial statements.
3. | Fair value measurements and fair value of financial instruments |
The authoritative guidance on fair value measurements establishes a three-tier fair value hierarchy for disclosure of fair value measurements as follows:
Level 1—Quoted prices in active markets for identical assets or liabilities. The Company’s deposits in a money market fund are Level 1 financial instruments.
Level 2—Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. The Company’s short-term investments including commercial paper, corporate debt and U.S. Treasury securities are Level 2 financial instruments.
Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The Company’s redeemable convertible preferred stock warrant liability (Redeemable Convertible Preferred Stock Warrant Liability) is a Level 3 financial instrument.
As of June 30, 2023 and December 31, 2022, financial assets measured at fair value on a recurring basis consist of cash and cash equivalents. The carrying amount of cash and cash equivalents was $
The carrying values of the Company’s accounts payable and accrued expenses and other current liabilities approximate their fair values due to the short-term nature of these liabilities.
Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and consider factors specific to the asset or liability.
The Company’s Level 3 liability that is measured at fair value on a recurring basis consists of the redeemable convertible preferred stock warrant liability.
Marketable securities, all of which are classified as available-for-sale securities, consisted of the following (in thousands):
As of December 31, 2022 | ||||||||||||
| Amortized |
| Unrealized |
| Unrealized |
| Estimated | |||||
cost | Gains | Losses | Fair Value | |||||||||
Commercial paper | $ | | $ | — | $ | — | $ | | ||||
Corporate debt securities |
| |
| — |
| ( |
| | ||||
U.S. Treasury securities |
| |
| — |
| ( |
| | ||||
Total | $ | | $ | — | $ | ( | $ | |
There were
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The following tables set forth the Company’s financial instruments that were measured at fair value on a recurring basis by level within the fair value hierarchy (in thousands):
June 30, 2023 | ||||||||||||
Total | ||||||||||||
| fair value |
| Level 1 |
| Level 2 |
| Level 3 | |||||
Liabilities: |
|
|
|
|
|
|
|
| ||||
Redeemable convertible preferred stock warrant liability | $ | | $ | — | $ | — | $ | |
December 31, 2022 | ||||||||||||
Total fair | ||||||||||||
value | Level 1 | Level 2 | Level 3 | |||||||||
Assets: |
|
|
|
|
|
|
|
| ||||
Cash and cash equivalents - money market funds | $ | | $ | | $ | — | $ | — | ||||
Commercial paper |
| |
| — |
| |
| — | ||||
Corporate debt securities |
| |
| — |
| |
| — | ||||
U.S. Treasury securities |
| |
| — |
| |
| — | ||||
Total | $ | | $ | | $ | | $ | — | ||||
Liabilities: |
|
|
|
|
|
|
|
| ||||
Redeemable convertible preferred stock warrant liability | $ | | $ | — | $ | — | $ | |
The following tables provide a summary of changes in the estimated fair value of the financial instruments using significant Level 3 inputs (in thousands):
Balance - January 1, 2023 |
| $ | |
| | ||
Balance - June 30, 2023 | $ | | |
Balance - January 1, 2022 | $ | | |
| ( | ||
Balance - December 31, 2022 | $ | |
During the periods presented, the Company has not changed the manner in which it values liabilities that are measured at estimated fair value using Level 3 inputs. There were no transfers within the hierarchy during the periods presented.
Redeemable Convertible Preferred Stock Warrant Liability
In connection with a note payable entered into on April 10, 2015, which was repaid in full in May 2019, the Company issued
The Company estimates the fair value of the Redeemable Convertible Preferred Stock Warrant Liability using an option pricing model and assumptions that are based on the individual characteristics of the warrants on the valuation date, as well as assumptions for fair value of the underlying redeemable convertible preferred stock, expected volatility, expected life, dividends and risk-free interest rate.
As of June 30, 2023, the fair value of the Redeemable Convertible Preferred Stock Warrant Liability was determined to be $
For the change in fair value of the Redeemable Convertible Preferred Stock Warrant Liability, the Company recorded other income of $
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loss. There was
4. | Prepaid expenses and other current assets |
Prepaid expenses and other current assets consist of the following (in thousands):
| As of |
| As of | |||
June 30, | December 31, | |||||
2023 | 2022 | |||||
Deferred financing costs | $ | | $ | — | ||
Prepaid clinical expenses |
| |
| | ||
Other |
| |
| | ||
Total | $ | | $ | |
5. | Accrued expenses and other current liabilities |
Accrued expenses and other current liabilities consist of the following (in thousands):
| As of |
| As of | |||
June 30, | December 31, | |||||
2023 | 2022 | |||||
Accrued clinical costs | $ | | $ | | ||
Accrued deferred financing costs |
| |
| — | ||
Accrued preclinical costs |
| — |
| | ||
Employees’ compensation |
| |
| | ||
Accrued research | | — | ||||
Other |
| |
| | ||
Total | $ | | $ | |
6. | Related parties |
Ascletis BioScience Co. Ltd
In January 2019, the Company entered into a license agreement that became effective in February 2019 with Ascletis, a subsidiary of Ascletis Pharma Inc. (Ascletis Pharma), biotechnology company incorporated in the Cayman Islands and headquartered in Hangzhou, China and a Company investor. The parties entered into this agreement with the intention to develop, manufacture, and commercialize the Company’s proprietary FASN inhibitor, denifanstat. Under the terms of the license agreement, the Company granted Ascletis and its affiliates an exclusive, royalty-bearing sublicensable right and license under the Company’s intellectual property to develop, manufacture, commercialize and otherwise exploit denifanstat and other products containing denifanstat-related compounds in Greater China, consisting of the People’s Republic of China, Hong Kong, Macau and Taiwan.
The Company will bear all expenses related to development activities in Greater China as part of a global Phase 2 trial, except for clinical operations and regulatory staff provided by Ascletis. The Company conducted all development activities in connection with the FASCINATE-1 Phase 2 clinical trial in the United States and Greater China at its sole expense, except for certain in-kind contributions by Ascletis in Greater China. Ascletis is solely responsible for all development activities in connection with obtaining and maintaining regulatory approvals for denifanstat in Greater China. The Company received $
The Company is eligible to receive development and commercial milestone payments from Ascletis in aggregate of up to $
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denifanstat, which is referred to as ASC40 in Greater China. Ascletis Pharma, through a subsidiary, also led the Series E preferred stock financing in February 2019.
There were
This license and Phase 2 research and development services components of this agreement are representative of a relationship with a customer and therefore are subject to ASC 606. In January 2022, Ascletis initiated dosing of a Phase 3 trial for recurrent GBM, potentially triggering a $
The Company and Ascletis concluded their discussions regarding the milestone in July 2023. The Company invoiced Ascletis for the milestone payment, with payment due before the end of August 2023. See Note 13.
7. | Commitments and contingencies |
Facility lease agreement
On March 12, 2019, the Company executed a
Operating lease cost for the three months ended June 30, 2023 and 2022 was $
The following are schedules by year of future maturities of the Company’s operating lease liabilities (in thousands):
June 30, | |||
2023 | |||
Remainder of 2023 |
| $ | |
2024 |
| | |
Total lease payments |
| | |
Less: interest |
| ( | |
Total | $ | |
December 31, | |||
2022 | |||
2023 |
| $ | |
2024 |
| | |
Total lease payments |
| | |
Less: interest |
| ( | |
Total | $ | |
Supplemental cash flow information related to leases was as follows (in thousands):
| Six months ended June 30, | Six months ended June 30, | ||||
| 2023 |
| 2022 | |||
Cash paid for amounts included in the measurement of lease liabilities: |
|
|
|
| ||
Operating cash flows from operating leases | $ | | $ | |
The weighted-average remaining lease term and discount rate related to the Company’s lease liabilities as of June 30, 2023 and December 31, 2022 were
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estimates of its incremental borrowing rate, as the discount rate implicit in the Company’s lease cannot be readily determined. As the Company does not have any outstanding debt, the Company estimates the incremental borrowing rate based on its estimated credit rating and available market information.
Guarantees and indemnifications
In the normal course of business, the Company enters into agreements that contain a variety of representations and provide for general indemnification. The Company’s exposure under these agreements is unknown because it involves claims that may be made against the Company in the future. In addition, the Company has entered into indemnification agreements with members of its board of directors and its executive officers that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers. To date, the Company has not paid any claims or been required to defend any action related to its indemnification obligations. As of June 30, 2023, the Company does not have any material indemnification claims that were probable or reasonably possible and consequently has not recorded related liabilities.
Legal
The Company is not party to any material legal proceedings at this time. From time to time, the Company may become involved in various legal proceedings that arise in the ordinary course of its business.
8. | Redeemable convertible preferred stock |
Prior to the IPO (see Note 13) the authorized, issued and outstanding shares of the redeemable convertible preferred stock, liquidation preferences and carrying values were as follows as of June 30, 2023 and December 31, 2022 (in thousands, except share numbers):
As of June 30, 2023 and December 31, 2022 | ||||||||||
|
| Issued and |
|
| ||||||
Authorized | Outstanding | Liquidation | Carrying | |||||||
Shares | Shares | Preference | Value | |||||||
Series A |
| |
| | $ | | $ | | ||
Series B |
| |
| |
| |
| | ||
Series B‑1 |
| |
| |
| |
| | ||
Series C |
| |
| |
| |
| | ||
Series D |
| |
| |
| |
| | ||
Series A’ |
| |
| |
| — |
| — | ||
Series B’ |
| |
| |
| — |
| — | ||
Series B‑1’ |
| |
| |
| — |
| | ||
Series C’ |
| |
| |
| — |
| — | ||
Series D’ |
| |
| |
| — |
| | ||
Series D‑1 |
| |
| |
| |
| | ||
Series E |
| |
| |
| |
| | ||
Series F |
| |
| |
| |
| | ||
Total |
| |
| | $ | | $ | |
In connection with the IPO, all of the Company’s outstanding redeemable convertible preferred stock automatically converted into
9. | Stockholders’ deficit |
Common stock
In connection with the adoption of an amendment to the Company’s tenth amended and restated certificate of incorporation filed March 27, 2023, the number of shares of common stock that the Company is authorized to issue increased from
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| As of |
| As of | |
June 30, | December 31, | |||
| 2023 |
| 2022 | |
Redeemable convertible preferred stock |
| |
| |
Series D redeemable convertible preferred stock warrants |
| |
| |
Options authorized and available for issuance |
| — |
| |
Options to purchase common stock |
| |
| |
Warrants to purchase common stock |
| |
| |
Total |
| |
| |
Redeemable convertible preferred stock warrant liability
In connection with a note payable entered into on April 10, 2015, which was repaid in full in May 2019, the Company issued
The Series D redeemable convertible preferred stock warrant has no voting rights, or other rights as a stockholder of the Company. The warrant is subject to adjustment in the event of any diluting dividends or distributions of the common stock, or any stock split, reverse stock split, recapitalization, reorganization or similar transaction. Upon any reclassification, exchange, substitution or other event, the number and or class of the securities and property that the holder would have received for the shares if this warrant had been issued immediately before such event will be adjusted.
The Company closed on its IPO on July 18, 2023 (see Note 13). Subsequently, the expiration date of the Series D Redeemable convertible preferred stock warrant was automatically extended until July 18, 2026, the third anniversary date of the effective date of the Company’s IPO. If the warrant has not been exercised prior to the expiration date, the warrant will be deemed to have been automatically exercised on the expiration date by cashless conversion.
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Stock warrants
The following tables summarize the Company’s outstanding common and redeemable convertible preferred stock warrants:
As of June 30, 2023 | ||||||||||||||
Number | Exercise | |||||||||||||
of | Price | Fair Value on | Fair Value | |||||||||||
Warrant | per | Expiration | Exercisable | Issuance | Recorded | |||||||||
Issuance Date |
| Shares |
| Share |
| Date |
| for |
| (in thousands) |
| Against | ||
June 2013 | | $ | | July 2023 | Common | $ | | Redeemable convertible preferred stock | ||||||
January 2014 |
| | $ | |
| January 2024 |
| Common | |
| Redeemable convertible preferred stock | |||
April 2015 |
| | $ | |
| April 2025 |
| Series D | |
| Debt |
As of December 31, 2022 | ||||||||||||||
| Number |
| Exercise |
|
|
|
| |||||||
of | Price | Fair Va |