Sagimet Biosciences Inc.
For the period ended Mar 31, 2025. Filed May 8, 2025.
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Mar 31, 2025 · Filed May 8, 2025
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Notes to Condensed Financial Statements (unaudited)
NOTES TO THE CONDENSED FINANCIAL STATEMENTS (unaudited)
| 1. | Description of Business and Basis of Presentation |
Description of business
Sagimet Biosciences Inc. (the Company), a Delaware corporation headquartered in San Mateo, California, is a clinical-stage biopharmaceutical company developing novel therapeutics called fatty acid synthase (FASN) inhibitors that target dysfunctional metabolic and fibrotic pathways in diseases resulting from the overproduction of the fatty acid, palmitate. The Company’s lead drug candidate, denifanstat, is an oral, once-daily pill and selective FASN inhibitor in development for metabolic dysfunction-associated steatohepatitis (MASH), acne, and select forms of cancer. FASCINATE-2, a Phase 2b clinical trial of denifanstat in MASH with liver biopsy-based primary endpoints, was successfully completed with positive results. Denifanstat has been granted Breakthrough Therapy designation by the FDA for the treatment of non-cirrhotic MASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis), and end-of-Phase 2 interactions with the FDA have been successfully completed, supporting the advancement of denifanstat into further development. Sagimet’s second FASN inhibitor, TVB-3567, a potent and selective small molecule FASN inhibitor, received IND clearance in March 2025, allowing initiation of a first-in-human Phase 1 clinical trial in acne. The Company’s license partner, Ascletis BioScience Co. Ltd. (Ascletis), is currently testing denifanstat in a Phase 3 trial in moderate to severe acne vulgaris and in a Phase 3 trial in recurrent glioblastoma multiforme (GBM) in combination with bevacizumab, both in China.
Basis of presentation
The accompanying financial statements have been prepared in accordance with accounting principles generally accepted (GAAP) in the United States. Any reference in these notes to applicable guidance is meant to refer to GAAP as found in the Accounting Standards Codification (ASC) and Accounting Standards Updates (ASU) promulgated by the Financial Accounting Standards Board (FASB).
These unaudited interim financial statements and accompanying notes should be read in conjunction with the Company’s annual financial statements and the notes thereto included in the Company’s Form 10-K, as filed with the Securities and Exchange Commission (SEC) on March 12, 2025. The accompanying interim financial statements as of March 31, 2025 and for the three months ended March 31, 2025 and 2024 are unaudited but include all adjustments that management believes to be necessary for a fair presentation of the periods presented. Interim results are not necessarily indicative of results for a full year. Balance sheet amounts as of December 31, 2024 have been derived from the audited financial statements as of that date.
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 revenues and expenses during the reporting period. Such estimates include accruals of research and development expenses, accrued costs for services rendered under agreements with third-party contract research organizations (CROs) 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.
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 those issued by companies that comply with the effective dates pursuant to public company FASB standards.
Liquidity
The accompanying unaudited financial statements have been prepared assuming the Company will continue as a going concern, which contemplates continuity of operations, realization of assets and the satisfaction of liabilities and commitments in the normal course of business. The Company will require substantial additional capital to fund its research and development and ongoing operating expenses. As of March 31, 2025, the Company has relied on public and private equity and debt financings and proceeds from licensing arrangements to fund its operations. The Company has incurred recurring losses and negative cash flows from operations since inception, and, as of March 31, 2025, had an accumulated deficit of $313.5 million and cash, cash equivalents and marketable securities of $144.6 million. The Company expects to incur additional losses and negative cash flows from operations for the foreseeable future.
In July and August 2023, the Company completed its initial public offering (IPO) and, inclusive of the partial exercise of the underwriters’ overallotment option, the Company sold an aggregate of 6,026,772 shares of Series A common stock at a public offering price of $16.00 per share and received $86.2 million in net proceeds. In January 2024, the Company completed a follow-on offering whereby it sold 9,000,000 shares of its Series A common stock at a price of$12.50 per share and received$104.7 million in proceeds, net of issuance costs of$7.8 million.
In August 2024, the Company entered into a Controlled Equity Offering Sales Agreement with Cantor Fitzgerald & Co. to establish an at-the-market offering (ATM Offering) through which the Company may sell, from time to time at its sole discretion, up to $75.0 million shares of its Series A common stock. There wereno sales under the ATM Offering during the three months ended March 31, 2025.
The Company expects that its cash, cash equivalents and marketable securities as of March 31, 2025 will be sufficient to fund the Company’s operating expenses for at least the next 12 months from the issuance of these financial statements. In the future, the Company will need to raise additional funds until it is able to generate sufficient revenues to fund its development activities. The Company’s future operating activities, coupled with its plans to raise capital or issue debt financing, may provide additional liquidity in the future, however these actions are not solely within the control of the Company and the Company is unable to predict the outcome of these actions to generate the liquidity ultimately required.
| 2. | Significant Accounting Policies |
The Company’s significant accounting policies are disclosed in the audited financial statements and the notes thereto, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the SEC on March 12, 2025. Since the date of those audited financial statements, there have been no material changes to the Company’s significant accounting policies.
Net loss per share attributable to common stockholders
Basic and diluted net loss per share is computed using the two-class method required for multiple classes of common stock and participating securities. The Company’s participating securities do not have a contractual obligation to share in the Company’s losses. As such, the net loss was attributed entirely to common stockholders for all periods presented. Basic net loss per common share attributable to common stockholders is calculated by dividing the net loss by the weighted-average number of common shares outstanding during the period, without consideration of potentially dilutive securities. Diluted net loss per share attributable to common stockholders is computed by dividing the net loss by the weighted-average number of common shares and potentially dilutive securities outstanding for the period. For purposes of the diluted net loss per share attributable to common stockholders’ calculation, common stock options, restricted stock units and common stock warrants are considered to be potentially dilutive securities. As the Company has reported a net loss for the periods presented, basic and diluted net loss per share attributable to common stockholders is the same as all potentially dilutive securities would have an anti-dilutive impact.
The following table presents the calculation of basic and diluted net loss per share for the three months ended March 31, 2025 and 2024 (in thousands, except share and per share data):
| | | | | | | |
|---|---|---|---|---|---|---|
| · · Three Months Ended March 31, | ||||||
| | | 2025 | 2024 | |||
| Numerator: | | | | | | |
| Net loss | | $(18,176) | | $(6,629) | ||
| Denominator: | | | | | | |
| Weighted-average shares of Series A and Series B common stock outstanding, basic and diluted | | 32,195,345 | | 29,039,427 | ||
| Net loss per share of Series A and Series B common stock outstanding, basic and diluted | | $(0.56) | | $(0.23) | ||
The following potentially dilutive securities have been excluded from the computation of diluted weighted-average shares of Series A and Series B common stock outstanding, as their effect would have been anti-dilutive:
| | | | | |
|---|---|---|---|---|
| · · Three Months Ended March 31, | ||||
| · 2025 · 2024 | ||||
| Options to purchase Series A common stock | | 5,494,659 | | 3,518,803 |
| Warrants to purchase Series A common stock | | 1,000 | | 1,000 |
| Unvested restricted stock units | | 1,098,399 | | 1,125,840 |
| Total | 6,594,058 | 4,645,643 | ||
New accounting pronouncements not yet adopted
The Company considers the applicability and impact of all ASUs. ASUs not discussed below were assessed and either determined to be not applicable or expected to have minimal impact on the Company’s financial statements.
In November 2024, the FASB issued ASU 2024-03,Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic220-40):Disaggregation of Income Statement Expenses, which requires public business entities to disclose, for interim and annual reporting periods, additional information about certain income statement expense categories. ASU 2024-03 is effective for annual periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. Early adoption is permitted and is effective on either a prospective basis or retrospective basis. The Company is currently evaluating the impact of the adoption of this standard on its financial statements and related disclosures.
In December 2023, the FASB issued ASU 2023-09,* Income Taxes (Topic 740)—*Improvements to Income Tax Disclosures, a final standard on improvements to income tax disclosures. The standard requires disaggregated information about a reporting entity's effective tax rate reconciliation as well as information on income taxes paid. The standard is intended to benefit investors by providing more detailed income tax disclosures that would be useful in making capital allocation decisions and applies to all entities subject to income taxes. The new standard is effective for annual periods beginning after December 15, 2024. The Company is currently evaluating the impact of the adoption of this standard on its disclosures and will adopt the ASU for its Annual Report on Form 10-K for the year ended December 31, 2025.
| 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.
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.
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.
As of March 31, 2025 and December 31, 2024, financial assets measured at fair value on a recurring basis consisted of cash equivalents and marketable securities. Cash equivalents consist primarily of money market funds and other investments that are readily convertible into cash and have maturities of three months or less at the time of acquisition. The fair value of cash equivalents was $64.2 million and $75.3 million as of March 31, 2025 and December 31, 2024, respectively. The Company considers marketable securities with maturities greater than three months at the time of acquisition to be available-for-sale securities. The fair value of available-for-sale securities was $79.9 million and $82.8 million as of March 31, 2025 and December 31, 2024, respectively. These available-for-sale securities have expected maturities ranging from 0.03 to 10.7 months. The fair value of marketable securities, which are Level 2 financial instruments, is based upon market prices quoted on the last day of the fiscal period or other observable market inputs. The Company obtains pricing information from its investment manager and generally determines the fair value of investment securities using standard observable inputs, including reported trades, broker-dealer quotes, bids and/or offers.
The Company evaluates securities with unrealized losses, if any, to determine whether the decline in fair value has resulted from credit loss or other factors, including various qualitative factors. As of March 31, 2025, the Company has not recognized any impairment or credit losses on the Company’s available-for-sale securities. While the Company classifies these securities as available-for-sale, the Company does not intend to sell its investments and based on its current plans, the Company currently believes it has the ability to hold these investments until maturity.
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 liabilities that are measured at fair value on a recurring basis consist of the Series A common stock warrant liability related to the warrant to purchase 1,000 shares of Series A common stock with an exercise price of $69.94 per share and an expiration date of July 18, 2026, the third anniversary date of the closing of the Company’s IPO. The fair value of Series A common stock warrant liability was immaterial as of March 31, 2025 and December 31, 2024, as well as the change in fair value during the three months ended March 31, 2025 and 2024. There were no transfers within the hierarchy during the periods presented.
The following tables set forth the Company’s financial assets that were measured at fair value on a recurring basis by level within the fair value hierarchy (in thousands):
| | | | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · · · March 31, 2025 | |||||||||||||||
| · · · Valuation · Amortized · Unrealized · Unrealized · | |||||||||||||||
| · · · Hierarchy · · cost · · Gains · · Losses · · Fair Value | |||||||||||||||
| Assets | | | | | | | | | | | | | | | |
| Cash equivalents: | | | | | | | | | | | | | | | |
| Money market funds | | | Level 1 | | $64,201 | | $— | | $— | | $64,201 | ||||
| Total cash equivalents | | | | | | 64,201 | | | — | | | — | | | 64,201 |
| Short-term marketable securities: | | | | | | | | | | | | | | | |
| Commercial paper | | Level 2 | | | 20,988 | | 4 | | (2) | | 20,990 | ||||
| Corporate debt securities | | | Level 2 | | | 4,465 | | | 2 | | | — | | | 4,467 |
| U.S. Treasury securities | | | Level 2 | | | 39,924 | | | 109 | | | — | | | 40,033 |
| Agency securities | | | Level 2 | | | 11,868 | | | — | | | (2) | | | 11,866 |
| Asset-backed securities | | | Level 2 | | | 2,486 | | | 10 | | | — | | | 2,496 |
| Total short-term marketable securities | | | | | | 79,731 | | | 125 | | | (4) | | | 79,852 |
| Total cash equivalents and marketable securities | | | | | $143,932 | | $125 | | $(4) | | $144,053 | ||||
| | | | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · · · · December 31, 2024 | |||||||||||||||
| · · · Valuation · Amortized · Unrealized · Unrealized · | |||||||||||||||
| · · · Hierarchy · · cost · · Gains · · Losses · · Fair Value | |||||||||||||||
| Assets | | | | | | | | | | | | | | | |
| Cash equivalents: | | | | | | | | | | | | | | | |
| Money market funds | | | Level 1 | | $72,800 | | $— | | $— | | $72,800 | ||||
| U.S. Treasury securities | | | Level 2 | | | 2,477 | | | — | | | — | | | 2,477 |
| Total cash equivalents | | | | | | 75,277 | | | — | | | — | | | 75,277 |
| Short-term marketable securities: | | | | | | | | | | | | | | | |
| Commercial paper | | Level 2 | | | 14,447 | | 25 | | (1) | | 14,471 | ||||
| Corporate debt securities | | | Level 2 | | | 6,909 | | | 7 | | | — | | | 6,916 |
| U.S. Treasury securities | | | Level 2 | | | 27,493 | | | 123 | | | — | | | 27,616 |
| Agency securities | | | Level 2 | | | 21,345 | | | 12 | | | (2) | | | 21,355 |
| Asset-backed securities | | | Level 2 | | | 5,030 | | | 22 | | | — | | | 5,052 |
| Total short-term marketable securities | | | | | | 75,224 | | | 189 | | | (3) | | | 75,410 |
| Long-term marketable securities: | | | | | | | | | | | | | | | |
| U.S. Treasury securities | | | Level 2 | | | 4,884 | | | 36 | | | — | | | 4,920 |
| Asset-backed securities | | | Level 2 | | | 2,480 | | | 8 | | | — | | | 2,488 |
| Total long-term marketable securities | | | | | | 7,364 | | | 44 | | | — | | | 7,408 |
| Total cash equivalents and marketable securities | | | | | $157,865 | | $233 | | $(3) | | $158,095 | ||||
| 4. | Prepaid Expenses and Other Current Assets |
Prepaid expenses and other current assets consisted of the following (in thousands):
| | | | | | | |
|---|---|---|---|---|---|---|
| | As of | |||||
| · · March 31, · · December 31, | ||||||
| · · 2025 · 2024 | ||||||
| Prepaid clinical costs | | $226 | | $436 | ||
| Prepaid research and development costs | | | 112 | | | 48 |
| Prepaid insurance | | | 277 | | | 577 |
| Deferred financing costs | | | 625 | | | 306 |
| Other | | 263 | | 157 | ||
| Total prepaid expenses and other current assets | | $1,503 | | $1,524 | ||
| 5. | Accrued Expenses and Other Current Liabilities |
Accrued expenses and other current liabilities consisted of the following (in thousands):
| | | | | | | |
|---|---|---|---|---|---|---|
| | As of | |||||
| · · March 31, · · December 31, | ||||||
| · · 2025 · 2024 | ||||||
| Accrued payroll-related costs | | $423 | | $1,358 | ||
| Accrued clinical costs | | | 665 | | | 528 |
| Accrued research and development costs | | | 1,829 | | | 516 |
| Accrued general and administrative costs | | | 938 | | | 544 |
| Accrued offering costs | | | 47 | | | — |
| Other | | 16 | | 5 | ||
| Total accrued expenses and other current liabilities | | $3,918 | | $2,951 | ||
| 6. | Commitments and Contingencies |
License and other agreements
Ascletis BioScience Co. Ltd
In January 2019, the Company entered into a license agreement that became effective in February 2019 with Ascletis BioScience Co. Ltd. (Ascletis), a subsidiary of Ascletis Pharma Inc. (Ascletis Pharma), a biotechnology company incorporated in the Cayman Islands and headquartered in Hangzhou, China. Ascletis Pharma, through a subsidiary, was the lead investor in the Company’s Series E redeemable convertible preferred stock financing in February 2019. The parties entered into this agreement with the intention to develop, manufacture, and commercialize the Company’s proprietary FASN inhibitor, denifanstat, which Ascletis refers to as ASC40. 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 is eligible to receive development and commercial milestone payments from Ascletis in aggregate of up to $122.0 million as well as tiered royalties ranging from percentages in the high single digits to mid-teens on future net sales of denifanstat in Greater China. The license and the research and development services components of this license agreement are representative of a relationship with a customer, and therefore, the Company evaluated the license agreement under the provisions of ASC 606,Revenue from Contracts with Customers. The developmental and commercial event-based milestone payments represent variable consideration, and the Company used the most likely amount method to estimate this variable consideration because the potential milestone payment is a binary event, as the Company will either receive the milestone payment or it will not. Given the high degree of uncertainty around achievement of these milestones, the Company determined the milestone amounts to be fully constrained and will not recognize revenue until the uncertainty associated with these payments is resolved. Any consideration related to royalties will be recognized if and when the related sales occur. The Company re-assesses the transaction price in each reporting period and when events whose outcomes are resolved or other changes in circumstances occur.
In July 2023, the Company entered into an Assignment and Assumption Agreement with Ascletis and Ascletis’ affiliate Gannex Pharma Co., Ltd. (Gannex) under which Ascletis, while remaining responsible for performance under the license agreement, assigned all of its rights and obligations under the license agreement to Gannex and Gannex assumed such rights and obligations, effective as of October 2019.
Facility Lease Agreement
On March 12, 2019, the Company executed a 38-month non-cancelable operating lease agreement for 3,030 square feet of office space for its headquarters facility in San Mateo, California, which commenced April 1, 2019. The lease provides for monthly lease payments of approximately $12,000 with annual increases. In December, 2021, the lease agreement was amended to extend the term of the lease through June 2024; in April 2024, the Company amended the lease agreement to (i) extend the lease through June 30, 2025 and (ii) increase the monthly lease payment to approximately $13,000 beginning on July 1, 2024, which resulted in an increase in the Company’s operating lease right-of-use asset and corresponding operating lease liability of $0.1 million on the amendment date.
Operating lease costs were $39,000 and $37,000 for the three months ended March 31, 2025, and 2024, respectively.
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 March 31, 2025, the Company does not have any material indemnification claims that were probable or reasonably possible and consequently has not recorded related liabilities.
Legal Proceedings
From time to time, the Company may become involved in various legal proceedings that arise in the ordinary course of its business. The Company records a liability for such matters when it is probable that future losses will be incurred and that such losses can be reasonably estimated. Significant judgment by the Company is required to determine both probability and the estimated amount. The Company is not party to any material legal proceedings as of March 31, 2025.
| 7. | Stock-Based Compensation |
The 2023 Stock Option and Incentive Plan (2023 Plan) was adopted by the board of directors, approved by the Company’s stockholders on July 4, 2023, and became effective on July 13, 2023, replacing the 2017 Equity Incentive Plan. The number of shares initially reserved for issuance under the 2023 Plan was 2,585,968. The number of shares will automatically increase each January 1, by (i)4% of the outstanding number of shares of the Company’s Series A common stock on the immediately preceding December 31 or (ii) a lesser number of shares as determined by the compensation committee of the board of directors. In accordance with the 2023 Plan, the shares reserved for issuance automatically increased by 855,016 shares on January 1, 2024, and by 1,226,994 shares on January 1, 2025. As of March 31, 2025, the aggregate maximum number of shares reserved for issuance under the 2023 Plan was 4,667,978, of which 1,670,598 shares were available for future grant. Option grants issued under the 2023 Plan are exercisable for up to 10 years from the date of issuance.
In March 2024, the Company established a pool of 1,000,000 shares of Series A common stock (Inducement Pool) from which equity grants in the form of options and restricted stock units may be issued as inducement for new employees to accept employment offers from the Company or for individuals returning to employment after a bona fide period of non-employment with the Company. Inducement Pool grants are granted outside of the 2023 Plan and do not require approval from the Company’s stockholders pursuant to the Nasdaq inducement grant exception in accordance with Nasdaq Listing Rule 5635(c)(4). In February 2025, the Company increased the number of shares available for issuance by 300,000 shares, increasing the total number of shares available for issuance under the Inducement Pool to 1,300,000 shares. As of March 31, 2025,404,017 shares were available for future grants from the Inducement Pool.
Total stock-based compensation recorded in the condensed statements of operations and comprehensive loss related to stock options and restricted stock units for employees and non-employees was as follows (in thousands):
| | | | | | | | |
|---|---|---|---|---|---|---|---|
| | Three Months Ended March 31, | ||||||
| · · 2025 · 2024 · | |||||||
| Stock options | | $1,223 | | $449 | | ||
| Restricted stock units | | 249 | | 310 | | ||
| Total stock-based compensation expense | | $1,472 | | $759 | | ||
| Included in: | | | | | | | |
| General and administrative expense | | $1,248 | | $513 | | ||
| Research and development expense | | 224 | | 246 | | ||
| Total stock-based compensation expense | | $1,472 | | $759 | | ||
Stock options
The Company grants stock options which consist of (i) time-based options, which vest and become exercisable, subject to the participant’s continued employment or service through the applicable vesting date and (ii) performance-based options, which vest based on performance measures against predetermined objectives that include successful completion of qualified equity offerings or announced
topline results for clinical trials and positive clinical results over a specified performance period. The Company’s time-based options have various vesting schedules that range from vesting immediately to vesting over afour-year period.
The following table summarizes stock option activity for the three months ended March 31, 2025 (in thousands, except share and per share data):
| · · · · · · · · · · | |||||||
|---|---|---|---|---|---|---|---|
| · · · · Weighted- · · | |||||||
| · · Number of · · · · · Average · · · | |||||||
| · · Shares · · Weighted- · · Remaining · · · | |||||||
| · · Underlying · · Average · · Contractual · · Aggregate | |||||||
| · · Outstanding · · Exercise · · Term · · Intrinsic | |||||||
| · · Options · · Price · · (in Years) · · Value (1) | |||||||
| Outstanding, January 1, 2025 | 4,462,517 | | $6.58 | 7.4 | | $619 | |
| Granted | 1,032,289 | | | 4.71 | | | |
| Forfeited/expired | (147) | | | 23.05 | | | |
| Outstanding, March 31, 2025 (2) | 5,494,659 | | $6.23 | 7.7 | | $26 | |
| Vested and expected to vest, March 31, 2025 | 5,494,659 | | $6.23 | 7.7 | | $26 | |
| Exercisable at March 31, 2025 | 2,741,368 | | $7.06 | 6.2 | | $— | |
| (1) | Aggregate intrinsic value represents the difference between the fair value of the Company’s Series A common stock on the last day of the fiscal period and the exercise price, multiplied by the number of options outstanding. |
| (2) | Includes 492,729 performance-based options with a weighted-average exercise price of $6.42, all of which were fully vested and exercisable. |
During the three months ended March 31, 2025 and 2024, the weighted average grant-date fair value per share of stock options granted was$3.71 and$4.34, respectively. The total intrinsic value of stock options exercised during the three months ended March 31, 2024, was$0.1 million. Additionally, during the three months ended March 31, 2024, cash received from the exercise of stock options was approximately$0.1 million.
As of March 31, 2025, there was $11.1 million of unrecognized compensation expense, which is expected to be recognized over a remaining weighted-average period of 2.7 years.
Restricted stock units
The Company’s restricted stock units generally vest over a four-year period in equal amounts on an annual basis, provided the employee remains continuously employed with the Company. The fair value of the restricted stock units is equal to the closing price of the Company’s Series A common stock on the grant date.
The following table summarizes restricted stock unit activity:
| | | | | | |
|---|---|---|---|---|---|
| · · · · Weighted-Average | |||||
| · Restricted · Grant Date | |||||
| · Stock Units · Fair Value | |||||
| Outstanding, January 1, 2025 | 844,382 | | $2.96 | ||
| Granted | 254,017 | | | 4.71 | |
| Outstanding, March 31, 2025 | | 1,098,399 | | $3.36 | |
As of March 31, 2025, the total unrecognized compensation expense related to unvested restricted stock units was$3.1 million, which is expected to be recognized over a remaining weighted-average period of 2.9 years.
Valuation assumptions
The fair value of each stock option granted was estimated on the date of grant using the Black-Scholes option pricing model using the following assumptions:
| · · · · · · | |||||
|---|---|---|---|---|---|
| | Three Months Ended March 31, | ||||
| · · 2025 · · 2024 | |||||
| Expected volatility | 95.0% | | 96.0% | ||
| Risk-free interest rate | 4.3% | | 4.1% | ||
| Dividend yield | — | | — | ||
| Expected term (in years) | 6.0 | | | 6.1 | |
The expected term is determined using the simplified method, which represents the average of the contractual term of the options and the weighted-average expected vesting period. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the option. The expected stock volatility rate is based on the volatility rates of comparable publicly held companies over a period equal to the expected term of the option. The Company utilizes a dividend yield of zero based on the fact that the Company has never paid cash dividends to stockholders and has no current intentions to pay cash dividends.
Employee stock purchase plan
The 2023 Employee Stock Purchase Plan (the ESPP) was adopted by the board of directors in July 2023 with an initial total of 215,497 shares of Series A common stock reserved for issuance. Under the ESPP plan, the amount of shares reserved automatically increases each January 1 through January 1, 2033, by the least of (i)215,497 shares of Series A common stock, (ii)1% of the outstanding number of shares of the Company’s Series A common stock on the immediately preceding December 31 or (iii) such lesser number of shares of Series A common stock as determined by the administrator of the ESPP. In accordance with the ESPP, the shares reserved for issuance automatically increased by 213,754 shares on January 1, 2024, and by 215,497 shares on January 1, 2025. As of March 31, 2025, the aggregate maximum number of shares reserved for issuance under the ESPP was 644,748. No shares of Series A common stock have been issued under the ESPP to date.
| 8. | Related Party Transactions |
Jinzi J. Wu, Ph.D., a member of the Company’s board of directors until June 2024, founded and serves as the chief executive officer of Ascletis, Gannex, and Ascletis Pharma.
During the three months ended March 31, 2024, the Company recognized $96,000 of expenses under the Ascletis license agreement, inclusive of manufacturing services fees charged by Ascletis pursuant to the manufacturing agreement with Ascletis which falls under the license agreement. These expenses are recorded in research and development expense in the statements of operations and comprehensive loss.
| 9. | Segment Reporting |
Operating segments are defined as components of an entity about which discrete financial information is evaluated regularly by the chief operating decision maker (CODM) in deciding how to allocate resources and assess performance. The Company operates and manages its business asone business segment, which is development and commercialization of therapeutics for the treatment of MASH and other diseases where FASN plays a pathogenic role. Accordingly, the Company hasone reportable segment. The Company has a single management team that reports to the Chief Executive Officer, the Company's CODM, who comprehensively manages the entire Company. The accounting policies of the segment are the same as those described in the summary of significant accounting policies.
When evaluating the Company’s financial performance, the CODM is regularly provided with more detailed expense information than what is included in the Company’s statements of operations and comprehensive loss. The CODM uses net loss, as reported in the statements of operations and comprehensive loss, in evaluating the performance of the segment. Decisions regarding resource allocation are made primarily during the annual budget planning process and reallocated as needed throughout the year. The measure of segment assets is reported on the balance sheets as total assets.
The following table shows a reconciliation of the Company’s net loss, including the significant expense categories regularly provided to and reviewed by the CODM, as computed under U.S. GAAP, to the Company’s total net loss in the statements of operations and comprehensive loss, for the three months ended March 31, 2025, and 2024 (in thousands):
| | | | | | | |
|---|---|---|---|---|---|---|
| · · | ||||||
| · · Three Months Ended March 31, | ||||||
| · 2025 · 2024 | ||||||
| External research and development expenses | | | 14,170 | | | 4,191 |
| External general and administrative expenses | | 2,252 | | 2,097 | ||
| Personnel costs | | | 1,951 | | | 1,478 |
| Stock-based compensation | | | 1,472 | | | 759 |
| Other segment items (1) | | (1,669) | | (1,896) | ||
| Segment net loss | | $18,176 | | $6,629 | ||
| (1) | Other segment items consist of (i) interest and other income, net and (ii) other internal operating research and development expenses. |
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.