Tenaya Therapeutics Inc
For the period ended Dec 31, 2023. Filed Mar 18, 2024.
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FY2023 · Filed Mar 18, 2024
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Notes to Financial Statements
Note 1. Organization and Description of the Business
Description of the Business
Tenaya Therapeutics, Inc. (the Company) was incorporated in the state of Delaware in August 2016 and is headquartered in South San Francisco, California. The Company is a clinical-stage biotechnology company focused on discovering, developing and delivering curative therapies that address the underlying drivers of heart disease. The Company’s lead product candidates include, TN-201, a gene therapy for myosin binding protein C3-associated hypertrophic cardiomyopathy, TN-401, a gene therapy for plakophilin 2-associated arrhythmogenic right ventricular cardiomyopathy and TN-301, a small molecule for heart failure with preserved ejection fraction.
Liquidity
The Company has incurred net losses since inception and expects such losses to continue in the future as it conducts research and development activities. As of December 31, 2023, the Company had an accumulated deficit of $403.3 million. The Company incurred a net loss of $124.1 million and $123.7 million during the years ended December 31, 2023 and 2022, respectively. The Company had $104.6 million of cash, cash equivalents and investments in marketable securities as of December 31, 2023.
Management recognizes the need to raise additional capital to fully implement its business plan. The Company may seek to raise capital through equity financings, debt financings, license agreements, strategic collaborations or other sources of financing. On February 12, 2024, the Company completed an underwritten offering and received net proceeds of $46.5 million. See Note 10 to the Company's financial statements for details. Management believes its existing cash, cash equivalents and investments in marketable securities as of December 31, 2023, along with the additional $46.5 million mentioned above, will be sufficient to fund the Company’s operations for at least the next twelve months following the date these financial statements are filed with the Securities and Exchange Commission (SEC).
Note 2. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (GAAP).
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, liabilities, and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Significant estimates and assumptions made in the accompanying financial statements include, but are not limited to, the valuation of equity-based awards and accrued expenses related to research and development activities. The Company bases its estimates on historical experience, the current economic environment, and on various other assumptions that are believed to be reasonable under the circumstances. Actual results may differ from those estimates or assumptions.
Fair Value Measurements
Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date. The accounting guidance establishes a three-tiered hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value as follows:
Level 1 - Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date.
Level 2 - Inputs other than quoted market prices included in Level 1 are either directly or indirectly observable for the asset or liability through correlation with market data at the measurement date and for the duration of the instrument’s anticipated life.
Level 3 - Inputs reflect management’s best estimate of what market participants would use in pricing the asset or liability at the measurement date. Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model.
To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement.
The Company’s cash and cash equivalents, prepaid expenses and other current assets, accounts payable and accrued expenses and other current liabilities approximate their fair value due to their short-term nature.
Concentrations of Credit Risk
Financial instruments that potentially subject the Company to concentration of risk consist principally of cash, cash equivalents and marketable securities. The Company maintains deposits in cash and cash equivalents in federally insured financial institutions that it believes have high credit quality. Such deposits may exceed federally insured limits. The Company is exposed to credit risk in the event of default by the financial institutions holding its cash and cash equivalents and the issuers of its investments in marketable securities to the extent recorded in the balance sheets. The Company has not experienced any losses on its deposits of cash and cash equivalents.
Risks and Uncertainties
The Company is subject to certain risks including, but not limited to, the ability to obtain future financing, possible failure of ongoing and future clinical trials, the need to obtain regulatory approvals for its product candidates, the need to successfully commercialize and gain market acceptance of the Company’s product candidates, competitive developments, protection of proprietary technology, the ability to make milestone, royalty or other payments due under licensing agreements, and the Company’s ability to attract and retain employees necessary to support its business plan.
Segment Information
The Company views its operations and manages its business as one operating segment, which is the business of discovering and developing potential treatments that address the underlying drivers of heart disease. The Company’s long-lived assets are located in the United States.
Cash and Cash Equivalents
The Company considers all highly liquid investments purchased with an original maturity of three months or less on the date of purchase to be cash equivalents. Cash equivalents primarily consist of money market funds that are stated at fair value.
Restricted Cash
The restricted cash primarily represents security deposits for the Company’s operating leases in South San Francisco, and Union City, California. The security deposits are in the form of a letter of credit secured by restricted cash.
Marketable Securities
The Company invests in marketable securities, primarily securities issued by the U.S. government and its agencies, commercial paper and corporate bonds. All marketable securities have been classified as available-for-sale andare carried at estimated fair value as determined based upon quoted market prices or pricing models for similar securities. Management determines the appropriate classification of its marketable debt securities at the time of purchase and reevaluates such designation at each balance sheet date. The Company evaluates securities for impairment at the end of each reporting period. Factors considered in the evaluation include whether a decline in fair value below the amortized cost basis is due to credit-related factors or non-credit-related factors, the financial condition and near-term prospect of the issuer, and the Company’s intent and ability to hold the investment to allow for anticipated recovery in fair value. A credit-related impairment is recognized as an allowance on the balance sheet with a corresponding adjustment to earnings. Any impairment that is not credit-related is reported as a component of other comprehensive loss. Realized gains and losses are included in other income (expense), net. The cost of securities sold is based on the specific-identification method. Interest earned on marketable securities is included in interest income.
Property and Equipment, Net
Property and equipment are stated at cost, less accumulated depreciation. Depreciation is computed using the straight-line method over the estimated useful lives of the assets, generally three tofive years. Leasehold improvements are amortized over the shorter of the assets’ expected lives or the remaining lease term. Costs for capital assets not yet placed into service are capitalized as construction in progress and are not depreciated until the asset is placed in service.
Upon retirement or sale, the cost of disposed assets and their related accumulated depreciation are removed from the balance sheets. Any resulting gains or losses on dispositions of property and equipment are included as a component of other income (expense), net, within the Company’s statements of operations and comprehensive loss. Repair and maintenance costs, which are not considered improvements and do not extend the useful life of property and equipment, are expensed as incurred.
Impairment for Long-Lived Assets
Long-lived assets, including construction in progress, are reviewed for impairment annually or whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by comparing the carrying amount of an asset to the estimated undiscounted future net cash flows expected to be generated by the asset. If the carrying amount of the asset exceeds its estimated future cash flows, an impairment charge is recognized in the amount by which the carrying amount of the asset exceeds the fair value of the asset. Fair value is determined through various valuation techniques including discounted cash flow models, quoted market values and third-party independent appraisals, as considered necessary. There wasno impairment of long-lived assets for any of the periods presented.
Leases
The Company determines if an arrangement is a lease at inception. Operating lease right-of-use (ROU) assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized based on the present value of lease payments over the lease term at the commencement date of the lease. ROU assets also include any initial direct costs incurred and any lease payments made at or before the lease commencement date, less any lease incentive received. The Company uses the rate implicit in the lease in determining the present value of lease payments and, if that rate is not readily determinable, the Company uses its incremental borrowing rate based on the information available at the date of lease commencement. The incremental borrowing rate reflects the rate of interest that a lessee would have to pay to borrow, on a collateralized basis over a similar term, an amount equal to the lease payments in a similar economic environment. The Company’s lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense for lease payments is recognized on a straight-line basis over the lease term.
The Company’s non-lease components are primarily related to property taxes, insurance, and common area maintenance, which vary based on future outcomes, and are recognized as rent expense when incurred.
Research and development (R&D) costs are expensed as incurred. Research and development expenses include, among others, consulting fees, salaries, benefits, travel, stock-based compensation, laboratory supplies and other non-capital equipment utilized for in-house research, allocated facilities and overhead costs, fees related to licensing agreements, fees paid to contract research organizations (CRO) that conduct research and development activities on the Company’s behalf and costs related to compliance with regulatory requirements.
Goods or services incurred for research and development activities that have not yet been invoiced are recorded as liabilities within accrued expenses and other current liabilities on the Company’s balance sheets.
The Company has and may continue to acquire the rights to licensed technology that represents in-process research and development to use and develop in the commercialization of new product candidates. The upfront payments made to acquire licenses, product or rights, or payments made related to future milestone payments are recognized as research and development expenses provided that there is no alternative future use of the rights in other research and development projects, up to the point of regulatory approval. Milestone payments are expensed when the specific milestone has been achieved.
Non-refundable advance payments for goods or services to be rendered as part of future research and development activities are capitalized on the Company’s balance sheets until the goods or services are received.
Classification between prepaid expenses and other current assets and other non-current assets is based on an evaluation of when the goods will be delivered and/or services will be performed, with such amounts subsequently amortized to expense once incurred.
The Company measures and records expense related to all equity awards granted to employees and non-employees in the statements of operations and comprehensive loss based on their grant date fair values, including stock options and restricted stock awards. For stock-based awards that vest subject to the satisfaction of a service requirement, the expense is recognized using the straight-line method over the requisite service period, which is generally the vesting period. Forfeitures are recognized as they occur.
The fair value of restricted stock awards is determined on the date of grant based on the estimated fair value of the Company’s common stock on that date.
For purposes of determining the estimated fair value of options granted to employees and nonemployees, the Company uses the Black-Scholes option pricing model. See Note 7 to the Company's financial statements for the specific assumptions used in applying the Black-Scholes valuation model.
Income Taxes
The Company accounts for income taxes using the asset and liability method. The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. Deferred tax assets and liabilities are determined based on the difference between the financial statement and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse.
A valuation allowance is recorded for deferred tax assets if it is more likely than not that some portion or all of the deferred tax assets will not be realized. As of December 31, 2023 and 2022, the Company has recorded a full valuation allowance on its net deferred tax assets.
Tax benefits related to uncertain tax positions are recognized when it is more likely than not that a tax position will be sustained during an audit. Interest and penalties, if any, related to unrecognized tax benefits are included within the provision for income tax.
Net Loss Per Share
Basicnet loss per share is calculated by dividing the net loss by the weighted-average number of shares of the Company’s common stock outstanding for the period, without consideration for potential dilutive shares of common stock. Basic shares of common stock outstanding include the weighted-average effect of the Company’s pre-funded warrants issued in November 2022 because the pre-funded warrants have a nominal exercise price. As the Company is in a loss position for the periods presented, diluted net loss per share is the same as basic net loss per share, since the effects of potentially dilutive securities are antidilutive. Shares related to early exercised stock options that are subjectto repurchase are excluded from the basic and diluted net loss per share calculation until the Company’s repurchase right lapses.
Emerging Growth Company Status
The Company is an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012 (JOBS Act). Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. The Company has elected to use this extended transition period for complying with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date that it (a) is no longer an emerging growth company or (b) affirmatively and irrevocably opts out of the extended transition period provided in the JOBS Act. As a result, these financial statements may not be comparable to companies that comply with the new or revised accounting pronouncements as of public company effective dates.
Recently Adopted Accounting Standards
In June 2016, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (ASU 2016-13), which replaces the existing incurred loss impairment model with an expected credit loss model. This standard requires companies to recognize an allowance for credit losses on available-for-sale debt securities rather than the prior approach of recording a reduction to the carrying value of the asset. ASU 2016-13 became effective for the Company beginning January 1, 2023. Theadoption of this standard didnot have a material impact on the Company's financial statements.
Recently Issued Accounting Pronouncements Note Yet Adopted
In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures(ASU 2023-09), which requires disaggregated information about a reporting entity’s effective tax rate reconciliation as well as information on income taxes paid. ASU 2023-09 is effective for the Company beginning January 1, 2025. The Company is evaluating the impact of this standard on its financial statements and related disclosures.
In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures(ASU 2023-07), which improves reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses. In addition, ASU 2023-07 enhances interim disclosure requirements, clarifies circumstances in which an entity can disclose multiple segment measures of profit or loss, provided new segment disclosure requirements for entities with a single reportable segment, and contains other disclosure requirements. ASU 2023-07 is effective for the Company beginning January 1, 2024. The Company is evaluating the impact of this standard on its financial statements and related disclosures.
Note 3. Fair Value Measurements
Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date. The accounting guidance establishes a three-tiered hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value as follows:
Level 1 - Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date.
Level 2 - Inputs other than quoted market prices included in Level 1 are either directly or indirectly observable for the asset or liability through correlation with market data at the measurement date and for the duration of the instrument’s anticipated life.
Level 3 - Inputs reflect management’s best estimate of what market participants would use in pricing the asset or liability at the measurement date. Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model.
The following tables summarize the Company’s financial assets measured at fair value on a recurring basis by level within the fair value hierarchy:
| ValuationHierarchy | AmortizedCost | UnrealizedGain | UnrealizedLoss | Fair Value | |
|---|---|---|---|---|---|
| (In thousands) | |||||
| Assets: | |||||
| Cash equivalents: | |||||
| Money market funds | Level 1 | 91 | — | — | 91 |
| U.S. treasuries | Level 1 | 3,595 | — | — | 3,595 |
| Commercial paper | Level 2 | 34,901 | — | (18) | 34,883 |
| Government agencies bonds | Level 2 | 6,389 | 1 | — | 6,390 |
| Marketable securities: | |||||
| U.S. treasuries | Level 1 | 16,182 | 4 | (15) | 16,171 |
| Commercial paper | Level 2 | 2,971 | — | (2) | 2,969 |
| Government agencies bonds | Level 2 | 39,897 | 6 | (82) | 39,821 |
| Total financial assets | $104,026 | $11 | $(117) | $103,920 | |
| ValuationHierarchy | AmortizedCost | UnrealizedGain | UnrealizedLoss | Fair Value | |
|---|---|---|---|---|---|
| (In thousands) | |||||
| Assets: | |||||
| Cash equivalents: | |||||
| Cash equivalents | Level 1 | $20,532 | $— | $— | $20,532 |
| Money market funds | Level 1 | 7,203 | — | — | 7,203 |
| Commercial paper | Level 2 | 11,972 | — | (4) | 11,968 |
| Government agencies bonds | Level 2 | 54,569 | 12 | — | 54,581 |
| Marketable securities: | |||||
| U.S. treasuries | Level 1 | 25,273 | 1 | (147) | 25,127 |
| Commercial paper | Level 2 | 43,605 | 4 | (125) | 43,484 |
| Corporate bonds | Level 2 | 2,696 | — | (18) | 2,678 |
| Government agencies bonds | Level 2 | 37,770 | 9 | (110) | 37,669 |
| Total financial assets | $203,620 | $26 | $(404) | $203,242 | |
Money market funds and U.S. treasury securities are classified as Level 1 because they are valued using quoted market prices in active markets for identical assets. Financial instruments classified within Level 2 of the fair value hierarchy are valued based on observable inputs or can be derived from non-binding quotes from the Company’s investment managers, which are based on proprietary valuation models of independent pricing services.
These models generally use inputs such as observable market data, quoted market prices for similar instruments, or historical pricing trends of a security relative to its peers.
The Company believes it is more likely than not that its marketable securities in an unrealized loss position will be held until maturity or the recovery of the cost basis of the investment. As of December 31, 2023, the Company hasnot recorded any allowance for credit losses on its investment securities. Based upon its quarterly impairment review, the Company determined that the unrealized losses were not attributed to credit risk, but were primarily driven by the broader change in interest rates. As of December 31, 2023, all available-for-sale marketable securities had remaining maturities of less thanone year.
The carrying amount of the Company’s remaining financial assets and liabilities, which include cash, receivables and payables, approximate their fair values due to their short-term nature.
Note 4. Balance Sheet Components
Property and Equipment, Net
Property and equipment, net, consists of the following:
| December 31,2023 | December 31,2022 | |
|---|---|---|
| (In thousands) | ||
| Leasehold improvements | $25,608 | $23,605 |
| Laboratory equipment | 19,973 | 20,537 |
| Manufacturing equipment | 17,716 | 17,468 |
| Construction in progress | 1,730 | 3,128 |
| Computer equipment and software | 1,614 | 1,060 |
| Furniture and fixtures | 976 | 910 |
| Total property and equipment | $67,617 | $66,708 |
| Less: accumulated depreciation and amortization | (24,340) | (15,676) |
| Total property and equipment, net | $43,277 | $51,032 |
Depreciation and amortization expense for the years ended December 31, 2023 and 2022, was $8.7 million and $6.5 million, respectively.
Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consist of the following:
| December 31,2023 | December 31,2022 | |
|---|---|---|
| (In thousands) | ||
| Accrued compensation and related expenses | $8,700 | $6,299 |
| Accrued research and development expenses | 2,583 | 3,214 |
| Accrued professional services | 743 | 482 |
| ESPP deduction liability | 88 | 124 |
| Accrued facility management services | 185 | — |
| Other current liabilities | 485 | 545 |
| Total accrued and other current liabilities | $12,784 | $10,664 |
Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consist of the following:
| December 31,2023 | December 31,2022 | |
|---|---|---|
| (In thousands) | ||
| Prepaid expenses | 5,783 | 4,044 |
| Tax credit receivable | — | 2,245 |
| Other current assets | 1,157 | 938 |
| Total prepaid expenses and other current assets | $6,940 | $7,227 |
Note 5. Commitments and Contingencies
Facility Leases
In December 2016, the Company entered into a lease agreement for office and laboratory space in South San Francisco, California. The lease expires in May 2025 and the Company may renew the lease term fortwo additional five-year periods.
In February 2021, the Company entered into a lease agreement for the Union City Facility. The lease commenced in May 2021 and has aten-year term withone five-year renewal option.
In November 2021, the Company entered into a short-term sublease agreement for additional office and laboratory space in South San Francisco, California with a lease term that was initially set to expire on June 30, 2022. In May 2022, the Company entered into an amendment to extend the term for the existing sublease premise through December 31, 2022. Under the amendment, the Company also subleased additional office and laboratory space at the same sublease premise through November 30, 2023. In October 2023, the Company entered into a second amendment for additional laboratory space and to extend the term of the sublease premise through November 30, 2024.
Information related to operating lease activity during the year ended December 31, 2023 was as follows (in thousands):
| Year Ended December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Operating lease cost | $4,356 | $3,714 |
| Variable lease cost | 1,265 | 1,209 |
| Short-term lease cost | 5 | 952 |
| Total lease cost | $5,626 | $5,875 |
| Operating lease right-of-use assets obtained in exchange for lease obligations | $1,448 | $2,224 |
| Cash paid for amounts included in the measurement of lease liabilities | $5,347 | $4,293 |
As of December 31, 2023, the Company’s operating leases had a weighted average remaining lease term of 5.1 years and a weighted average discount rate of 9.3%. Future minimum lease payments under the Company’s operating leases as of December 31, 2023 were as follows:
| Amount | |
|---|---|
| (In thousands) | |
| 2024 | $5,277 |
| 2025 | 2,445 |
| 2026 | 1,386 |
| 2027 | 1,428 |
| 2028 | 1,471 |
| Thereafter | 4,006 |
| Total undiscounted future minimum lease payments | $16,013 |
| Imputed interest | (3,589) |
| Total operating lease liabilities | $12,424 |
Purchase Commitments
The Company enters into contractual agreements with various suppliers in the normal course of its business, including vendors that provide machinery and equipment. All contracts are terminable, with varying provisions regarding termination. If a contract with a specific vendor were to be terminated, the Company would only be obligated for the products or services that the Company had received through the time of termination.
Indemnification
From time to time, the Company may become involved in litigation and other legal actions. The Company estimates the range of liability related to any pending litigation where the amount and range of loss can be estimated. The Company records its best estimate of a loss when the loss is considered probable. Where a liability is probable and there is a range of estimated loss with no best estimate in the range, the Company records a charge equal to at least the minimum estimated liability for a loss contingency when both of the following conditions are met: (i) information available prior to issuance of the financial statements indicates that it is probable that a liability had been incurred at the date of the financial statements and (ii) the range of loss can be reasonably estimated. The Company was not involved in any material litigation as of December 31, 2023 and 2022.
In the normal course of business, the Company enters into agreements that may include indemnification provisions. Pursuant to such agreements, the Company may indemnify, hold harmless and defend an indemnified party for losses suffered or incurred by the indemnified party. In some cases, the indemnification will continue after the termination of the agreement. The maximum potential amounts of future payments the Company could be required to make under these provisions is not determinable. In addition, the Company has entered into indemnification agreements with its directors and certain officers that may 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. As of December 31, 2023 and 2022, the Company did not have any material indemnification claims that were probable or reasonably possible and, consequently, has not recorded any related liabilities.
Note 6. Stockholders’ Equity
Common Stock
The holders of common stock are entitled to one vote per share on all matters to be voted on by the stockholders of the Company and are entitled to dividends, if and when declared by the board of directors, subject to the prior rights of the preferred stockholders. Common stock issued and outstanding on the balance sheets and statements of stockholders’ equity includes shares related to early exercised options and restricted stock that are subject to repurchase. Common stock issued and outstanding is reduced for any repurchases of early exercised stock options and restricted stock.
“At-the-Market” Equity Offering
On August 10, 2022, the Company entered into a sales agreement (Sales Agreement) with Leerink Partners LLC (formerly SVB Securities LLC) to establish an at-the-market (ATM) offering defined in Rule 415 under the Securities Act. Pursuant to the Sales Agreement, the Company is permitted to offer and sell, from time to time, shares of its common stock having a maximum aggregate offering price of up to $75.0 million. As of December 31, 2023, the Company may issue and sell up to approximately $71.0 million in additional shares of its common stock under the ATM.
Follow-On Offerings
On November 21, 2022, the Company completed an underwritten public offering of 22,613,307 shares of its common stock at a price of $2.60 per share and, to certain investors in lieu of common stock, pre-funded warrants to purchase 6,236,693 shares of its common stock at a price of $2.599 per pre-funded warrant. The pre-funded warrants can be exercised at any time after issuance for an exercise price of $0.001 per share, subject to certain ownership limitations. In addition, the Company granted the underwriters a 30-day option to purchase up to an additional 4,327,500 shares of its common stock to cover overallotments, if any, at $2.60 per share. On November 29, 2022, the underwriters partially exercised the option and purchased an additional 2,816,409 shares of Company’s common stock. As of December 31, 2023, pre-funded warrants for 5,934,176 shares of common stock remained outstanding. .
As of December 31, 2023, total shares of common stock reserved for issuance, on an as-if converted basis, are as follows:
| Outstanding stock options and awards | 9,431,710 |
|---|---|
| Outstanding pre-funded warrants | 5,934,176 |
| Shares available for further issuance under the 2021 Equity Incentive Plan | 965,665 |
| Shares available for further issuance under the 2021 Employee Stock Purchase Plan | 1,405,394 |
| Total | 17,736,945 |
Note 7. Stock-Based Compensation
2021 Equity Incentive Plan
Under the Company's 2021 Equity Incentive Plan (2021 Plan),4,000,000 shares of the Company’s common stock were initially reserved for issuance of equity awards to employees, directors, and consultants, under terms and provisions established by the board of directors. The number of shares of common stock available for issuance under the 2021 Plan automatically increases on the first day of January for a period often years, commencing on January 1, 2022, in an amount equal to the lesser of:4,000,000 shares;4% of the outstanding shares of the Company’s common stock as of the last day of the immediately preceding year; or such other amount as the board of directors may determine.
Total shares reserved and available for grant under the 2021 Plan as of December 31, 2023 are 965,665.
Stock Option Activity
The following table summarizes stock option activity:
| Shares | Weighted-AverageExercisePrice | Weighted-AverageRemainingContractualLife | AggregateIntrinsicValue | |
|---|---|---|---|---|
| (in dollars) · (Years) · (In thousands) | ||||
| Outstanding as of December 31, 2022 | 5,210,182 | $10.01 | ||
| Granted | 3,311,758 | $3.36 | ||
| Exercised | (10,875) | $2.71 | ||
| Cancelled | (167,631) | $5.85 | ||
| Outstanding as of December 31, 2023 | 8,343,434 | $7.47 | 8.12 | $2,380 |
| Exercisable as of December 31, 2023 | 3,821,798 | $7.81 | 7.43 | $1,700 |
The aggregate intrinsic value is the value of the Company’s closing stock price on the last trading day of the year in excess of the weighted-average exercise price multiplied by the number of options outstanding or exercisable. The total intrinsic value of options exercised during the years ended December 31, 2023 and 2022, was $36.7 thousand and $0.2 million.
The weighted-average grant-date fair value of options granted during the years ended December 31, 2023 and 2022 was $2.62 and $9.80 per share.
As of December 31, 2023, there was $25.0 million of unrecognized stock-based compensation cost related to stock options, which is expected to be recognized over an estimated weighted-average period of 2.5 years.
Stock Option Valuation
The fair value of the Company’s stock option awards is estimated on the date of grant using the Black-Scholes option pricing model using the following assumptions:
The assumptions used to determine the fair value of options granted were as follows. Each of these inputs is subjective, involve inherent uncertainties, and generally requires significant judgment. The assumptions used to determine the fair value of the awards represent management’s best estimates.
| Year EndedDecember 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Expected term (in years) | 5.5 – 6.1 | 5.5 – 6.1 |
| Expected volatility | 93% – 95% | 95% – 97% |
| Risk-free interest rate | 3.4% – 4.5% | 1.6% – 4.2% |
| Expected dividend yield | —% | —% |
Expected Term— The Company determines the expected term, which represents the period that stock-based awards are expected to be outstanding, in accordance with the simplified method due to its limited operating history, which is presumed to be the mid-point between the contractual term and the vesting period.
Expected Volatility— As there is limited trading history for the Company’s common stock, the Company determines its computation of expected volatility on the historical volatility of a representative group of public companies with similar characteristics to the Company, including stage of product development and life science industry focus. The historical volatility is calculated based on a period of time commensurate with the expected term assumption.
Risk-Free Interest Rate— The Company bases the risk-free interest rate on U.S. Treasury zero coupon issues in effect at the time of grant for periods corresponding with the expected term assumption.
Expected Dividend Yield— The expected dividend yield is assumed to be zero as the Company has never paid and has no plans to pay any dividends on its common stock.
Restricted Stock Units
Restricted stock units (RSUs) are awards that entitle the holder to receive freely tradable shares of the Company’s common stock upon the completion of a specific period of continued service. RSUs are generally subject to forfeiture if employment terminates prior to the release of vesting restrictions. RSUs are valued at the market price of the underlying common stock on the date of grant. The Company recognizes noncash compensation expense for the fair value of RSUs on a straight-line basis over the requisite service period of the awards. The following table summarizes activity of RSUs granted to employees with service-based vesting under the 2021 Plan.
| Shares | Weighted Average Grant DateFair Value per Share | Weighted-AverageRemainingContractualLife | AggregateIntrinsicValue | |
|---|---|---|---|---|
| (in dollars) · (Years) · (In thousands) | ||||
| Unvested as of December 31, 2022 | 459,192 | $4.07 | ||
| Granted | 911,813 | $3.06 | ||
| Vested | (254,172) | $3.61 | ||
| Forfeited | (28,557) | $3.70 | ||
| Unvested as of December 31, 2023 | 1,088,276 | $3.34 | 1.19 | $3,526 |
As of December 31, 2023, there was $3.0 million of unrecognized stock-based compensation cost related to RSUs, which is expected to be recognized over an estimated weighted-average period of 2.3 years.
2021 Employee Stock Purchase Plan
Under the Company's 2021 Employee Stock Purchase Plan (ESPP), the Company initially reserved 800,000 shares for future issuance. The number of shares of common stock available for issuance under the ESPP automatically increases on the first day of each fiscal year beginning with 2022 in an amount equal to the lesser of:800,000 shares;1% of the outstanding shares of the Company’s common stock as of the last day of the immediately preceding year; or such other amount as the board of directors may determine. As of December 31, 2023,1,405,394 shares were reserved for future issuance under the ESPP. Under the Company’s ESPP, employees are generally eligible to participate and can purchase shares on each purchase date established semi-annually through payroll deductions at the lower of 85% of the fair market value of the Company’s stock at the commencement of the offering period or each purchase date of the offering period. Each offering period spans 6 months. The ESPP permits eligible employees to purchase common stock through payroll deductions for up to 15% of qualified compensation, up to an annual limit of $25,000 per the Internal Revenue Service. The first offering period commenced in January 2022. For the years ended December 30, 2023 and 2022, the stock-based compensation expense for ESPP was not material.
The following table summarizes stock-based compensation recognized in the Company’s statements of operations and comprehensive loss:
| Year EndedDecember 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Research and development | $7,039 | $4,914 |
| General and administrative | 8,270 | 6,553 |
| Total stock-based compensation | $15,309 | $11,467 |
Note 8. Income Taxes
No provision for or benefit from income taxes was recorded during the years ended December 31, 2023 and 2022. The Company has established a full valuation allowance against its net deferred tax assets due to the uncertainty regarding the realization of such assets. All losses to date have been incurred in the United States. Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes, as well as operating losses and tax credit carryforwards.
Effective Tax Rate Reconciliation
The effective tax rate of the Company’s provision for income taxes differs from the federal statutory rate and the effective tax rate reconciliation is as follows:
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| U.S. federal taxes at statutory rate | 21.0% | 21.0% |
| State taxes (net of federal benefit) | 1.2 | 1.2 |
| Credits | 3.7 | 2.8 |
| Stock-based compensation | (0.3) | (0.3) |
| Change in valuation allowance | (24.4) | (24.1) |
| Other | (1.2) | (0.6) |
| Total | —% | —% |
A reconciliation of the beginning and ending amount of unrecognized tax benefits is as follows:
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| (In thousands) | ||
| Balance at beginning of year | $3,141 | $1,470 |
| Additions based on tax positions related to current year | 1,423 | 1,588 |
| Additions based on tax positions related to prior years | — | 83 |
| Reductions for tax positions related to prior years | (43) | — |
| Balance at end of year | $4,521 | $3,141 |
The Company does not expect that its uncertain tax positions will materially change in the next twelve months. The reversal of the uncertain tax benefits would not impact the Company’s effective tax rate as the Company continues to maintain a full valuation allowance against its deferred tax assets.
The Company files tax returns in U.S. federal and state jurisdictions with varying statutes of limitations. Due to net operating loss and credit carryforwards, all of the tax years since inception through the 2023 tax year remain subject to examination by the U.S. federal and state authorities. The Company is currently not subject to any income tax audits by federal or state taxing authorities.
Deferred Income Taxes
The tax effects of significant items comprising the Company’s deferred income taxes are as follows:
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| (In thousands) | ||
| Deferred tax assets: | ||
| Net operating losses | $52,757 | $41,256 |
| Capitalized research and development expenditure | 29,318 | 17,045 |
| Tax credits | 15,047 | 9,347 |
| Lease liability | 2,613 | 3,176 |
| Stock-based compensation | 2,880 | 1,631 |
| Accrued expenses and other | 1,713 | 1,368 |
| Total deferred tax assets | 104,328 | 73,823 |
| Valuation allowance | (101,290) | (71,129) |
| Deferred tax assets, net of valuation allowance | 3,038 | 2,694 |
| Deferred tax liabilities: | ||
| Right-of-use asset | (2,098) | (2,453) |
| Property and equipment | (940) | (241) |
| Net deferred tax assets | $— | $— |
Beginning January 1, 2022, the Tax Cuts and Jobs Act eliminated the option to deduct research and development expenditures in the current year and requires taxpayers to capitalize such expenses pursuant to Internal Revenue Code (IRC) Section 174. The capitalized expenses are amortized over a 5-year period for domestic expenses and a 15-year period for foreign expenses.
The tax benefit of net operating losses, capitalized research expenses, temporary differences and credit carryforwards are recorded as an asset to the extent that the Company assesses that realization is more likely than not. Realization of the future tax benefits is dependent on the Company’s ability to generate sufficient taxable income within the carryforward period. As a result of the Company’s recent history of operating losses, the Company believes that recognition of deferred tax assets arising from the above-mentioned future tax benefits is currently not likely to be realized and, accordingly, has provided a full valuation allowance. The valuation allowance increased by $30.2 million and $29.8 million during the years ended December 31, 2023 and 2022. The increase in valuation allowance during the year ended December 31, 2023, was primarily due to the increase in deferred tax assets from 2023 federal net operating losses and the IRC Section 174 capitalized expenses.
Net Operating Loss and Tax Credit Carryforwards
As of December 31, 2023, the Company’s net operating loss and tax carryforwards are summarized as follows:
| (In thousands) | Amount | Expiration in years |
|---|---|---|
| Net operating losses, federal (post-December 31, 2017) | $224,796 | Do Not Expire |
| Net operating losses, federal (pre-January 1, 2018) | $3,093 | Begins to Expire 2036 |
| Net operating losses, state | $63,212 | Begins to Expire 2036 |
| Tax credits, federal | $14,730 | Begins to Expire 2036 |
| Tax credits, state | $6,856 | Do Not Expire |
Under Section 382 of the Internal Revenue Code of 1986, as amended, the ability to utilize net operating loss carryforwards or other tax attributes, such as research tax credits, in any taxable year may be limited if the Company has experienced an “ownership change”. This annual limitation may result in the expiration of net operating losses and credits before utilization. As of December 31, 2023, the Company concluded that there were no ownership changes during 2023. The Company’s ability to use its remaining net operating loss carryforwards may be further limited if the Company experiences a Section 382 ownership change as a result of future changes in its stock ownership.
The Company recognizes interest and penalties related to taxes and uncertain tax positions as a component of income tax expense. During the years ended December 31, 2023 and 2022, no interest and penalties were accrued by the Company.
Note 9. Net Loss Per Share
Basic and diluted loss per share are computed by dividing net loss by the weighted-average number of common shares outstanding during the reporting period. Basic weighted-average shares of common stock outstanding includes the weighted-average effect of the Company’s pre-funded warrants.
The following potentially dilutive securities were excluded from the calculation of diluted net loss per share for the periods presented because the effect would have been anti-dilutive:
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Outstanding stock options and restricted stock units | 9,431,710 | 5,669,374 |
| Restricted stock subject to future vesting | — | 853 |
| Total | 9,431,710 | 5,670,227 |
Note 10. Subsequent Events
On February 12, 2024, the Company completed an underwritten offering of 8,888,890 shares of its common stock at a price of $4.50 per share and, to an investor in lieu of common stock, pre-funded warrants to purchase 2,222,271 shares of its common stock at a price of $4.499 per each pre-funded warrant. The pre-funded warrants can be exercised at any time after issuance for an exercise price of $0.001 per share, subject to certain ownership limitations. The Company received net proceeds of approximately $46.5 million, after deducting underwriting discounts and commissions of approximately $3.0 million and offering expenses of approximately $0.5 million.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.