PMV Pharmaceuticals Inc
For the period ended Dec 31, 2023. Filed Feb 29, 2024.
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FY2023 · Filed Feb 29, 2024
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Notes to Consolidated Financial Statements
- Formation and Business of the Company
Organization
PMV Pharmaceuticals, Inc. (the “Company”) was incorporated in the state of Delaware in March 2013. Since inception, the Company has devoted substantially all of its time and efforts to performing research and development activities and raising capital. The Company is a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53. The Company’s headquarters are located at One Research Way, Princeton, New Jersey.
The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry including, but not limited to, technical risks associated with the successful research, development and manufacturing of product candidates, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations and the ability to secure additional capital to fund operations. Current and future programs will require significant research and development efforts, including extensive preclinical and clinical testing and regulatory approval prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel, and infrastructure. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales.
The Company has incurred net losses and negative cash flows from operations since its inception. During the year ended December 31, 2023, the Company incurred a net loss of $68,960 and used $55,657 of cash for operations. As of December 31, 2023, the Company had an accumulated deficit of $310,003. Cash, cash equivalents, and marketable securities were$228,562 as of December 31, 2023. Management expects to incur substantial additional operating losses for the next several years and may need to obtain additional debt or equity financings in order to complete development of its products, obtain regulatory approvals, launch and commercialize its products and continue research and development programs. The Company believes it has adequate cash, cash equivalents, and marketable securities to operate for at least the next 12 months from the date of issuance of these consolidated financial statements.
- Summary of Significant Accounting Policies
Basis of Presentation
The audited consolidated financial statements are prepared in accordance with United States generally accepted accounting principles (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”).
The accompanying consolidated financial statements include our accounts and the accounts of our wholly owned subsidiary, PMV Pharma Australia Pvt Ltd. All significant intercompany transactions and balances have been eliminated upon consolidation. These consolidated financial statements are presented in United States ("U.S.") Dollars, which is also the functional currency of the Company.
These consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the ordinary course of business. The Company has limited operating history and its prospects are subject to risks, expenses and uncertainties frequently encountered by companies in the biotechnology industry.
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 and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting period. The Company bases its estimates and assumptions on historical experience when available and on various factors that it believes to be reasonable under the circumstances. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, research and development costs, accrued research and development costs and related prepaid expenses, and the fair values of common stock, convertible preferred stock and stock-based compensation. Actual results could differ materially from those estimates.
Fair Value of Financial Instruments
The Company discloses and recognizes the fair value of its assets and liabilities using a hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. 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 hierarchy gives the highest priority to valuations based upon unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to valuations based upon unobservable inputs that are significant to the valuation (Level 3 measurements). The guidance establishes three levels of the fair value hierarchy as follows:
Level 1 - Inputs that reflect unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date.
Level 2 - Inputs other than quoted prices that are observable for the asset or liability either directly or indirectly, including inputs in markets that are not considered to be active.
Level 3 - Inputs are unobservable in which there is little or no market data available, which require the reporting entity to develop its own assumptions that are unobservable.
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.
Cash, Cash Equivalents and Marketable Securities
Management considers all highly liquid investments with original maturities of three months or less to be cash equivalents.
The Company’s marketable debt securities have been classified and accounted for as available-for-sale. The Company classifies its marketable debt securities as either short-term or long-term based on each instrument’s underlying contractual maturity date. Marketable debt securities with maturities of 12 months or less are classified as short-term and marketable debt securities with maturities greater than 12 months are classified as long-term. The Company’s marketable debt securities are carried at fair value, with unrealized gains and losses, net of taxes, reported as a component of accumulated other comprehensive loss in stockholders’ equity. Premiums and discounts on marketable debt securities are amortized into earnings over the life of the security and recorded on the interest income, net line of the income statement. For the years ended December 31, 2023, 2022, and 2021, the Company recorded$5,386 of accretion, $628 of accretion and $550 of amortization, respectively.
Restricted cash as of December 31, 2023 includeda $822 deposit at the Company’s commercial bank underlying a stand-by letter of credit issued in favor of a landlord (See Note 6) and is classified in current assets.
Comprehensive Loss and Accumulated Other Comprehensive Income (Loss)
Other comprehensive income (loss) is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources, including unrealized gains and losses on investments and foreign currency translation gains and losses.
Leases
At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the circumstances present. The Company accounts for a contract as a lease when it has the right to control the asset for a period of time while obtaining substantially all of the asset’s economic benefits. The Company determines the initial classification and measurement of its operating right-of-use (“ROU”) assets and operating lease liabilities at the lease commencement date, and thereafter if modified. The lease term includes any renewal options that the Company is reasonably assured to exercise. The Company’s policy is to not record leases with a lease term of 12 months or less on its balance sheets. Furthermore, the Company has elected the practical expedient to not separate lease and non-lease components by class of underlying asset for its existing leases. The Company’s only existing leases are for office and laboratory space.
The ROU asset represents the right to use the leased asset for the lease term. The lease liability represents the present value of the lease payments under the lease. The present value of lease payments is determined by using the interest rate implicit in the lease, if that rate is readily determinable; otherwise, the Company uses its estimated secured incremental borrowing rate for that lease term.
Lease expense for operating leases is recognized on a straight-line basis over the reasonably assured lease term based on the total lease payments and is included in operating expense in the consolidated statements of operations.
Payments due under each lease agreement include fixed and variable payments. Variable payments relate to the Company’s share of the lessor’s operating costs associated with the underlying asset and are recognized when the event on which those payments are assessed occurs. Variable payments have been excluded from the lease liability and associated right-of-use asset. Neither of the Company’s leases contain residual value guarantees.
The interest rate implicit in lease agreements is typically not readily determinable, and as such, the Company utilizes the incremental borrowing rate to calculate lease liabilities, which is the rate incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment.
Property and Equipment
Property and equipment are recorded at cost net of accumulated depreciation. Property and equipment are depreciated using the straight‑line method over the estimated useful lives of the assets, generally five years, except for leasehold improvements, which are amortized over the shorter of the useful life of the asset or the remaining term of the lease.
Upon retirement or sale of assets, the cost and related accumulated depreciation are removed from the balance sheet and the resulting gain or loss is reflected in operations. Repairs and maintenance costs are charged to operations as incurred.
Impairment of Long-Lived Assets
Long-lived assets, are tested for recoverability whenever events or changes in the business environment indicate that the carrying amount of the assets may not be fully recoverable. Factors considered by the Company when deciding when to perform an impairment review include significant underperformance of the business against expectations, significant negative industry or economic trends and significant changes or planned changes in the use of the assets. If an impairment review is performed to evaluate a long-lived asset for recoverability, the Company compares forecasts of undiscounted cash flows resulting from the use and eventual disposition of the long-lived asset to its carrying value. An impairment loss would be recognized when estimated undiscounted future cash flows resulting from the use of an asset are less than its carrying amount. The impairment loss would be based on the excess of the carrying value of the impaired asset over its current fair value. To date, the Company has not recorded any impairment losses on long-lived assets.
All costs associated with research and development are expensed as incurred. Research and development expenses include costs directly attributable to the conduct of research and development programs, including compensation costs, which includes allocated stock-based compensation, salary payroll taxes, employee benefits; materials; supplies; depreciation on and maintenance of research equipment; the cost of services provided by outside contractors; and the allocable portions of facility costs, such as rent, utilities, insurance, repairs and maintenance, depreciation, and general support services. The Company records accruals for estimated research and development expenses, comprising payments for work performed by third party vendors, clinical research organizations, clinical manufacturing organizations and others. Some of these vendors bill monthly based on actual services performed, while others bill periodically based upon achieving certain contractual milestones. For the latter, the Company accrues the expenses as goods or services are used or rendered. Research and development activities related to patient enrollment are accrued as patients enter and progress through the trial. In the event that the Company prepays fees, the Company records the prepayment as a prepaid asset and periodically evaluate the prepaid asset in conjunction with the related accrued research and development expenses.
Stock‑Based Compensation
The Company’s share-based compensation program allows for grants of stock options and restricted stock units. Grants are awarded to employees and non-employees, including directors.
The Company accounts for stock-based employee compensation arrangements in accordance with provisions of ASC 718, Compensation – Stock Compensation(“ASC 718”). ASC 718 requires the recognition of compensation expense, using a fair-value based method, for costs related to all share-based payments including stock options. ASC 718 requires companies to estimate the fair value of share-based payment awards on the date of grant using an option pricing or equity valuation model that is applied in a manner consistent with the fair value measurement objectives of ASC 718, is based on established principles of financial theory and reflects all of the substantive terms and conditions of the award. The Company uses the Black-Scholes option-pricing model (“Black-Scholes”) to value stock option grants to employees, non-employees and directors. The fair value of the Company’s common stock is used to determine the fair value of restricted stock units and stock options.
The Black-Scholes option pricing model requires inputs based on certain subjective assumptions, including (i) the expected stock price volatility, (ii) the expected term of the award, (iii) the risk-free interest rate and (iv) expected dividends. The historical volatility is calculated based on a period of time commensurate with expected term assumption. The Company uses the simplified method to calculate the expected term for options granted to employees whereby the expected term equals the arithmetic average of the vesting term and the original contractual term of the options due to its lack of sufficient historical data. The risk-free interest rate is based on U.S. Treasury securities with a maturity date commensurate with the expected term of the associated award. The expected dividend yield is assumed to bezero as the Company has never paid dividends and has no current plans to pay any dividends on its common stock. The Company recognizes forfeitures as they occur.
The Company’s stock-based compensation awards are subject to service-based vesting conditions. Compensation expense related to awards to employees and directors with service-based vesting conditions is recognized on a straight-line basis based on the grant date fair value over the associated service period of the award, which is typically the vesting term.
Segment Reporting
Operating segments are identified as components of an enterprise for which separate discrete financial information is available for evaluation by the Company’s Chief Operating Decision Maker to make decisions with respect to resource allocation and assessment of performance. To date, the Company has viewed its operations and manages its business asone operating and reporting segment.
Net Loss per Share
Basic net income (loss) per share is computed by dividing the net income (loss) by the weighted average number of shares of common stock outstanding for the years ended December 31, 2023 and 2022. Diluted net income (loss) per share is computed by dividing the diluted net income (loss) by the weighted average number of shares of common stock, including potential dilutive common shares assuming the dilutive effect of outstanding stock options and unvested restricted common stock, as determined using the treasury stock method. For periods in which the Company has reported net losses, diluted net loss per share is the same as basic net loss per share, since dilutive shares of common stock are not assumed to have been issued if their effect is antidilutive.
Income Taxes
The Company accounts for income taxes in accordance with ASC 740, Income Taxes ("ASC 740"), which requires that deferred tax assets and liabilities be recognized using enacted tax rates for the effect of temporary differences between the book and tax bases of recorded assets and liabilities. Under ASC 740, the liability method is used in accounting for income taxes. Deferred tax assets and liabilities are determined based on the differences between financial reporting and the tax basis of assets and liabilities and are measured using the enacted tax rates and law that will be in effect when the differences are expected to reverse. ASC 740 also requires that deferred tax assets be reduced by a valuation allowance if it is more likely than not that some or all of the deferred tax assets will not be realized. The Company evaluates annually the realizability of the deferred tax assets by assessing the valuation allowance and by adjusting the amount of such allowance, if necessary. The factors used to assess the likelihood of realization include forecast of future taxable income and available tax planning strategies that could be implemented to realize the net deferred tax assets. In 2023 and 2022, the Company recorded a full valuation allowance for the deferred tax assets based on the historical loss and the uncertainty regarding the ability to project future taxable income. In future periods if the Company is able to generate income, the Company may reduce or eliminate the valuation allowance.
The Company accounts for uncertain tax positions in accordance with ASC 740. ASC 740 prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax provision that an entity takes or expects to take in a tax return. Additionally, ASC 740 provides guidance on derecognition, classification, interest and penalties, accounting in interim periods, disclosures, and transition. Under ASC 740, an entity may only recognize or continue to recognize tax positions that meet a "more likely than not" threshold. In accordance with this accounting policy, the Company recognizes accrued interest and penalties related to unrecognized tax benefits as a component of income tax.
Recent Accounting Pronouncements
In November 2023, the Financial Accounting Standards Board (the "FASB") issued ASU No. 2023-07, "Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures." This amended guidance applies to all public entities and aims to improve reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses, to enable investors to develop more decision-useful financial analyses. This guidance is effective for fiscal years beginning after December 15, 2023 and interim periods within fiscal years beginning after December 15, 2024. Early adoption is permitted. We are currently analyzing the impact that ASU No. 2023-07 will have on our consolidated financial statements.
In December 2023, the FASB issued ASU No. 2023-09, "Income Taxes (Topic 740): Improvements to Income Tax Disclosures." This amended guidance applies to all entities and broadly aims to enhance the transparency and decision usefulness of income tax disclosures. For public business entities, the amendments in this Update are effective for fiscal years beginning after December 15, 2024. Early adoption is permitted for any annual periods for which financial statements have not been issued or made available for issuance. We are currently analyzing the impact that ASU No. 2023-09 will have on our consolidated financial statements.
Concentration of Credit Risk and Other Risks and Uncertainties
Financial instruments that potentially subject the Company to significant concentrations of credit risk consist of cash and cash equivalents and marketable securities. The Company maintains its cash, cash equivalents and marketable securities in accounts at high quality financial institutions. The Company has not experienced any credit losses and does not believe it is exposed to any significant credit risk on these funds. Cash and cash equivalents include a checking account and a money market account held at one financial institution. At times, such deposits may be in excess of insured limits. The Company has not experienced any losses on its deposits of cash and cash equivalents. The Company’s marketable debt securities are carried at fair value and include any unrealized gains and losses. Any investments with unrealized losses are considered to be temporarily impaired.
The Company’s future results of operations involve a number of risks and uncertainties. Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations include, but are not limited to, rapid technological change, uncertainty of market acceptance of the product, competition from substitute products and larger companies, protection of proprietary technology, any future strategic relationships and dependence on key individuals.
Products developed by the Company require clearances from the U.S. Food and Drug Administration or other international regulatory agencies prior to commercial sales. There can be no assurance the Company’s product candidates will receive the necessary clearances. If the Company is denied clearance, clearance is delayed or it is unable to maintain clearance, it could have a materially adverse impact on the Company.
Subsequent Events
We considered events or transactions occurring after the balance sheet date, but prior to the issuance of the consolidated financial statements, for potential recognition or disclosure in our consolidated financial statements. All significant subsequent events have been properly disclosed in the consolidated financial statements.
- Financial Instruments and Fair Value Measurements
The Company’s financial instruments consist of money market funds, U.S. government debt securities and corporate debt securities. The following tables show the Company’s cash equivalents and available-for-sale securities’ carrying amounts and fair values as of December 31, 2023 and 2022:
| As of December 31, 2023(in thousands) | |||||||
|---|---|---|---|---|---|---|---|
| CarryingAmount | Gross Unrealized Gains | Gross Unrealized Losses | FairValue | Quotedpriced inactivemarkets(Level 1) | Significantotherobservableinputs(Level 2) | Significantunobservableinputs(Level 3) | |
| Financial assets | |||||||
| Money market funds | $37,694 | $— | $— | $37,694 | $37,694 | $— | $— |
| Corporate securities | 69,995 | 48 | — | 70,043 | 5,577 | 64,466 | — |
| Government securities | 120,670 | 143 | — | 120,813 | 92,297 | 28,516 | — |
| Total financial assets | $228,359 | $191 | $— | $228,550 | $135,568 | $92,982 | $— |
| As of December 31, 2022(in thousands) | |||||||
| CarryingAmount | Gross Unrealized Gains | Gross Unrealized Losses | FairValue | QuotedPriced inActiveMarkets(Level 1) | SignificantOtherObservableInputs(Level 2) | SignificantUnobservableInputs(Level 3) | |
| Financial assets | |||||||
| Money market funds | $106,861 | $— | $— | $106,861 | $106,861 | $— | $— |
| Corporate securities | 103,755 | 21 | (185) | 103,591 | — | 103,591 | — |
| Government securities | 31,942 | — | (281) | 31,661 | 20,981 | 10,680 | — |
| Total financial assets | $242,558 | $21 | $(466) | $242,113 | $127,842 | $114,271 | $— |
Cash and Cash Equivalents– As of December 31, 2023, the Company had aggregate cash and cash equivalents of$37,706, including cash equivalents of $37,694, consisting of money market funds. As of December 31, 2022, the Company had aggregate cash and cash equivalents of $108,297, including cash equivalents of $106,861, consisting of money market funds. Money market funds and certificates of deposit are classified within level 1 of the fair value hierarchy because they are valued using quoted market prices in active markets, whereas corporate debt securities are classified within level 2 of the fair value hierarchy because they are valued using inputs other than quoted prices that are observable for the asset or liability either directly or indirectly.
Marketable Securities– Marketable securities of $190,856 as of December 31, 2023, consisted of corporate debt securities of $70,043 and government debt securities of $120,813. There were $165,351 current marketable securities and $25,505 noncurrent marketable securities as of December 31, 2023. Marketable securities of $135,252 as of December 31, 2022, consisted of corporate debt securities of $103,591 and government debt securities of $31,661. There were $132,757 current marketable securities and $2,495 noncurrent marketable securities as of December 31, 2022.
As of December 31, 2023 and 2022, aggregated gross unrealized losses of available-for-sale investments were not material, and accordingly, no allowance for credit losses was recorded.
- Property and Equipment, Net
| December 31, | ||
|---|---|---|
| (in thousands) | 2023 | 2022 |
| Machinery & equipment | $3,089 | $2,448 |
| Computers | 13 | 13 |
| Furniture & fixtures | 69 | 69 |
| Leasehold improvements | 10,765 | 409 |
| Assets not placed in service | — | 10,200 |
| Total property and equipment | 13,936 | 13,139 |
| Less: Accumulated depreciation | (3,270) | (2,184) |
| Property and equipment, net | $10,666 | $10,955 |
Depreciation expense for the years ended December 31, 2023, 2022, and 2021 was$1,257, $315, and $307, respectively.
- Accrued Expenses
Accrued expenses consists of the following:
| December 31, | ||
|---|---|---|
| (in thousands) | 2023 | 2022 |
| Accrued compensation | $4,498 | $2,897 |
| Accrued research and development costs | 5,270 | 4,259 |
| Accrued legal and professional services | 172 | 152 |
| Total | $9,940 | $7,308 |
- Commitments and Contingencies
Operating Leases
In June 2015, the Company executed a noncancelable operating lease for approximately 13,000 square feet of laboratory, research and development, and office space in Cranbury, New Jersey. This location operated as the Company's headquarters until March 2023.
In June 2017, the Company obtained an additional noncancelable operating lease for approximately 6,000 square feet of laboratory space in the same corporate center. Both leases were set to expire in June 2022. In January 2022, the Company signed a lease extension for both leases for up toone additional year through June 2023, with the option toterminate upon 120 days of written notice, with an increase in base rent as per the lease extension. The leases were terminated as of June 2023.
In August 2018, the Company executedtwo noncancelable operating leases. One lease for approximately 6,000 square feet for vivarium, laboratory and general office space in South Brunswick, New Jersey. The lease was set to expire in July 2022. In January 2022, the Company signed a lease extension for up toone additional year through July 2023, with the option toterminate upon 120 days of written notice, with an increase in base rent as per the lease extension. The lease was terminated as of June 2023. The second lease is for office space in Lexington, Massachusetts, that expired in August 2023.
In January 2021, the Company signed a lease for 50,581 square feet of office and laboratory space at One Research Way in Princeton, New Jersey. That lease term extends through 2032, has afive-year extension option, and replaced the Company’s two existing facilities as the Company’s headquarters in March 2023. Payment under this lease will total $19,889 through May 2032. The Company received a lease incentive of $4,046 from the lessor for a buildout of laboratory, vivarium, and office space, to be reimbursed to the Company in 2022 and 2023. Management estimated the timing and amounts of reimbursements and included them as a reduction of lease payments when initially measuring the lease liability and right-of-use asset upon commencement. Since the inception date of the lease, $3,806 of reimbursements were received. For the year ended December 31, 2023, $837 of reimbursements were received.
The components of lease cost for the years ended December 31, 2023, 2022, and 2021 are as follows:
| Year Ended December 31, | |||
|---|---|---|---|
| (in thousands) | 2023 | 2022 | 2021 |
| Operating lease cost | $1,913 | $2,215 | $1,691 |
| Variable lease cost | 914 | 991 | 704 |
| Total lease cost | $2,827 | $3,206 | $2,395 |
Amounts reported in the balance sheet for leases where the Company is the lessee as of December 31, 2023, and 2022, were as follows:
| As of December 31, | ||
|---|---|---|
| Operating Leases (in thousands, except lease term and discount rate data): | 2023 | 2022 |
| Right-of-use assets, operating leases | $8,382 | $9,539 |
| Operating lease liabilities, current | $852 | $528 |
| Operating lease liabilities, non-current | 12,434 | 13,448 |
| Total operating lease liabilities | $13,286 | $13,976 |
| Weighted-average remaining lease term (years) | 8.42 | 9.08 |
| Weighted-average discount rate | 5.75% | 5.75% |
Other information related to leases for the years ended December 31, 2023, 2022, and 2021, respectively, were as follows:
| Year Ended December 31, | |||
|---|---|---|---|
| (in thousands) | 2023 | 2022 | 2021 |
| Net cash paid (received) for amounts included in the measurement of lease liabilities | $1,447 | $(1,089) | $717 |
| Leased assets obtained in exchange for new or modified operating lease liabilities | — | 987 | 10,318 |
Future minimum lease payments, net of reimbursements, remaining as of December 31, 2023, under operating leases by fiscal year were as follows:
| Fiscal year | (in thousands) |
|---|---|
| 2024 | $1,574 |
| 2025 | 1,869 |
| 2026 | 1,925 |
| 2027 | 1,983 |
| 2028 | 2,042 |
| Thereafter | 7,453 |
| Total lease payments | $16,846 |
| Less: Present Value Adjustment | (3,560) |
| Present value of lease payments | $13,286 |
Rent expense recorded for the years ended December 31, 2023, 2022, and 2021, were $1,913, $2,215, and $1,691 respectively.
Contingencies
From time to time, the Company may have certain contingent liabilities that arise in the ordinary course of its business activities. The Company accrues a liability for such matters when future expenditures are probable and such expenditures can be reasonably estimated.
- Stockholders' Equity
The Company is authorized to issue up to 1,000,000,000 shares of common stock with a par value of $0.00001 per share, and 5,000,000 shares of preferred stock with a par value of $0.00001 per share. As of December 31, 2023 and 2022, there were 51,445,862 and 45,771,332 shares of common stock issued and outstanding, respectively.
Common stockholders are entitled to receive dividends if and when declared by the board of directors subject to the rights of any preferred stockholders. As of December 31, 2023, no dividends on common stock had been declared by the Company.
As of December 31, 2023 and 2022, the Company had reserved shares of common stock for issuance as follows:
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Options issued and outstanding | 6,973,464 | 5,278,771 |
| Shares available for future stock option and RSU grants | 4,474,411 | 4,618,292 |
| Shares available for employee stock purchase plan | 1,056,832 | 705,559 |
| Total | 12,504,707 | 10,602,622 |
ATM Program
On October 4, 2021, the Company entered into an at-the-market offering program (the “ATM Program”) pursuant to which, the Company may offer and sell shares of its common stock having aggregate gross sales proceeds of up to $150.0 million from time to time. For the year ended December 31, 2023, the Company sold 5,149,446 shares of common stock under the ATM Program at a weighted average price of $6.97 per share, for total proceeds of $35.1 million, net of fees. As of December 31, 2023, the Company has approximately $113.8 million remaining in gross proceeds available for future issuances of common stock under the ATM Program.
- Stock Plan
2020 Equity Incentive Plan
The 2020 Equity Incentive Plan (the “2020 Plan”) was approved by the board of directors on September 24, 2020. The 2020 Plan provides for the grant of incentive stock options, non-qualified stock options, stock appreciation rights, restricted stock units, restricted stock awards, unrestricted stock awards, cash-based awards and dividend equivalent rights to the Company’s officers, employees, directors and consultants. The number of shares of common stock initially reserved for issuance under the 2020 Plan was 4,406,374, which shall be increased, upon approval by the board of directors, on January 1, 2021 and each January 1 thereafter, in an amount equal to the least of (i)4,406,374 shares of common stock, (ii) five percent (5%) of the outstanding common stock on the immediately preceding December 31, or (iii) such number of common stock determined by the board of directors no later than the immediately preceding December 31. For 2022, the board’s compensation committee, as the 2020 Plan administrator, exercised its discretion under clause (iii) to increase the number of shares of common stock reserved for issuance under the 2020 Plan by a lesser amount of 1,363,084 shares, effective as of January 1, 2022. For 2023, the board’s compensation committee, as the 2020 Plan administrator, exercised its discretion under clause
(iii)to increase the number of shares of common stock reserved for issuance under the 2020 Plan by a lesser amount of 1,830,853 shares, effective as of January 1, 2023. For 2024, the board’s compensation committee, as the 2020 Plan administrator, exercised its discretion under clause (iii) to increase the number of shares of common stock reserved for issuance under the 2020 Plan by a lesser amount of 2,572,174 shares, effective as of January 1, 2024. As of December 31, 2023, there were 4,474,411 shares available for issuance under the 2020 Plan.
On September 9, 2022, the Company granted 374,899 Restricted Stock Units (RSUs) to employees pursuant to an employee retention program approved by the Board's compensation committee. The RSU’s have graded vesting on an annual basis fortwo years of continuous service, as per the 2020 Plan.
The table below summarizes the annual grant activity under the 2020 Plan as of December 31, 2023:
| Shares Available for Grant | |
|---|---|
| Balances, December 31, 2022 | 4,618,292 |
| Shares reserved for issuance | 1,830,853 |
| Options granted | (2,062,125) |
| Options forfeited / cancelled | 70,291 |
| RSU's forfeited | 17,100 |
| Balances December 31, 2023 | 4,474,411 |
2020 Employee Stock Purchase Plan
The 2020 Employee Stock Purchase Plan (the “2020 ESPP”) was approved by the board of directors on September 24, 2020. A total of 400,752 shares of common stock were initially reserved for issuance under this plan, which shall be increased, upon approval by the board of directors, on January 1, 2021 and each January 1 thereafter, to the lesser of (i)801,504 shares of common stock, (ii)1% of the outstanding shares of common stock on the last day of the immediately preceding fiscal year, or (iii) an amount determined by the board of directors or any of its committees no later than the last day of the immediately preceding fiscal year. For 2022, the board waived theannual increase to the shares reserved under the 2020 ESPP. For 2023, the 2020 ESPP reserved shares were increased under clause (iii) by 457,713 shares, effective as of January 1, 2023. For 2024, the 2020 ESPP reserved shares were increased under clause (iii) by 514,434 shares, effective as of January 1, 2024. On May 20, 2023, employees exercised their right to purchase 20,113 shares under the 2020 ESPP. On November 21, 2023, employees exercised their right to purchase 86,327 shares under the 2020 ESPP. As of December 31, 2023,202,345 shares are issued or outstanding, and there were 1,056,832 shares available for issuance, under the 2020 ESPP.
Stock Options
The following table summarizes option activity for the year ended December 31, 2023:
| Options Outstanding | ||||
|---|---|---|---|---|
| Weighted-Average | ||||
| Weighted · Remaining · Aggregate | ||||
| Number | Average | Contractual | Intrinsic | |
| of | Exercise | Life | Value | |
| Options | Price | (in years) | (in 000s) | |
| Balances, December 31, 2022 | 5,278,771 | $10.40 | 6.82 | $17,244 |
| Options granted | 2,062,125 | $5.84 | ||
| Options forfeited / cancelled | (70,291) | $13.75 | ||
| Options exercised | (297,141) | $0.59 | ||
| Balances December 31, 2023 | 6,973,464 | $9.44 | 7.01 | $990 |
| Vested and expected to vest | 6,973,464 | $9.44 | 7.01 | $990 |
| Exercisable | 4,175,906 | $8.95 | 5.79 | $990 |
The weighted average grant date fair value of stock options granted during the years ended December 31, 2023, 2022, and 2021, was $4.03, $10.92, and $20.03, respectively.
The aggregate intrinsic value of options vested and exercisable as of December 31, 2023 and 2022 is calculated based on the difference between the exercise price and the fair value of our common stock. The intrinsic value of options exercised in 2023, 2022, and 2021, was $892, $3,764, and $18,534, respectively.
As of December 31, 2023, the total compensation cost related to nonvested service-based awards not yet recognized is $18,866. The weighted-average period over which the nonvested awards is expected to be recognized is 2.5 years.
The Company estimated the fair value of stock options using the Black-Scholes options valuation model. The fair value of employee stock options is being amortized on a straight-line basis over the requisite service period of the awards. The fair value of employee stock options was estimated using the following assumptions:
| Year Ended December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Risk-free interest rate | 3.45% - 4.65% | 1.48% - 4.34% | 0.35% - 1.30% |
| Expected life (in years) | 5.50 - 6.25 | 5.50 - 6.44 | 5.50 - 6.44 |
| Dividend yield | 0% | 0% | 0% |
| Expected volatility | 75.21% - 77.72% | 76.33% - 81.00% | 76.50% - 79.90% |
The weighted average assumptions used to estimate the fair value of stock purchase rights under the ESPP are as follows:
| Year Ended December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Risk-free interest rate | 5.41% | 3.44% | 0.04% |
| Expected life (in years) | 0.49 | 0.49 | 0.5 |
| Dividend yield | 0% | 0% | 0% |
| Expected volatility | 76.27% | 77.00% | 77.83% |
Risk Free Interest Rate: The risk-free rate is based on the U.S. Treasury yields in effect at the time of grant for periods corresponding with the expected term of the option.
Expected Term: The Company uses the simplified method to calculate expected term described in the SEC’s Staff Accounting Bulletin No. 107, which takes into account vesting term and expiration date of the options.
Dividend Yield: The Company has never declared or paid any cash dividends and does not plan to pay cash dividends in the foreseeable future, and therefore, used an expected dividend yield ofzero in the valuation model.
Volatility: Volatility is based on the historical volatility of the Company's publicly traded shares for the expected term.
Restricted Stock Units
The following table presents RSU activity under the 2020 Plan as of December 31, 2023:
| Number ofStock Units | Weighted-Average Grant Date Fair Value | |
|---|---|---|
| Unvested shares at December 31, 2022 | 374,899 | $13.6 |
| Granted | — | — |
| Vested | (121,503) | 13.6 |
| Forfeited | (17,100) | 13.6 |
| Unvested shares at December 31, 2023 | 236,296 | 13.6 |
As of December 31, 2023, there was $1,671 of unrecognized compensation cost related to RSUs that are expected to vest. These costs are expected to be recognized over a weighted average remaining vesting period of 0.7 years.
Stock-based compensation expense recorded under ASC 718 related to stock options and RSU's granted and common stock issued under the 2020 ESPP were allocated to research and development and general and administrative expense as follows:
| For the Year Ended December 31, | |||
|---|---|---|---|
| (in thousands) | 2023 | 2022 | 2021 |
| Research and development | $5,518 | $3,466 | $1,440 |
| General and administrative | 6,857 | 6,729 | 3,900 |
| Total stock-based compensation | $12,375 | $10,195 | $5,340 |
Stock-based compensation expense by award type included within the consolidated statements of operations is as follows:
| For the Years Ended December 31, | |||
|---|---|---|---|
| (in thousands) | 2023 | 2022 | 2021 |
| Stock options | $9,745 | $9,174 | $4,938 |
| Restricted stock units | 2,413 | 790 | — |
| Employee stock purchase plan | 217 | 231 | 402 |
| Total stock-based compensation | $12,375 | $10,195 | $5,340 |
- Income Taxes
The income tax provision (benefit) for the years ended December 31, 2023, 2022, and 2021 are as follows (in thousands):
| For the Years Ended December 31, | ||||||
|---|---|---|---|---|---|---|
| 2023 · 2022 · 2021 | ||||||
| Current: | ||||||
| Federal | $ | - | $ | - | $ | - |
| State | 2 | (9) | 23 | |||
| Total current | 2 | (9) | 23 | |||
| Deferred: | ||||||
| Federal | $ | - | $ | - | $ | - |
| State | - | - | - | |||
| Total deferred | - | - | - | |||
| Total provision (benefit) | $2 | $(9) | $23 | |||
A reconciliation of income tax computed at the statutory federal income tax rate to the provision (benefit) for income taxes included in the accompanying consolidated statements of operations for the Company is as follows:
| For the Years Ended | |||
|---|---|---|---|
| December 31,2023 | December 31,2022 | December 31,2021 | |
| Income tax provision at statutory rate | 21% | 21% | 21% |
| State income taxes, net of federal benefit | 6% | 7% | 9% |
| Tax credits | 3% | 3% | 3% |
| Stock compensation | (1)% | 0% | 5% |
| Executive compensation limitation | (1)% | (1)% | 0% |
| Other | 0% | 0% | (1)% |
| Change in valuation allowance | (28)% | (30)% | (37)% |
| Effective income tax rate | 0% | 0% | 0% |
For the years ended December 31, 2023, 2022, and 2021, the Company’s effective tax rate is below the federal statutory income tax rate of 21% primarily due to state income taxes, net of federal benefit and the Company’s position to establish a full valuation allowance on its deferred tax assets.
The tax effect of temporary differences and carryforwards that give rise to significant portions of the deferred tax assets and liabilities are presented below:
| As of December 31, | ||||
|---|---|---|---|---|
| 2023 · 2022 | ||||
| Deferred tax assets: | ||||
| Net operating loss carryforwards | $56,701 | $49,451 | ||
| Stock compensation | 3,707 | 2,905 | ||
| Capitalized research expenditures | 22,154 | 13,563 | ||
| Research and development credits | 8,993 | 6,856 | ||
| Accrued expenses and other | 1,064 | 911 | ||
| Operating lease liabilities | 3,735 | 3,969 | ||
| Total deferred tax assets | 96,354 | 77,655 | ||
| Valuation allowance | (93,778) | (74,917) | ||
| Deferred tax assets recognized | 2,576 | 2,738 | ||
| Deferred tax liabilities: | ||||
| Right-of-use assets | (2,357) | (2,709) | ||
| Fixed assets and depreciation | (219) | (29) | ||
| Total deferred tax liabilities | (2,576) | (2,738) | ||
| Net deferred tax assets | $ | - | $ | - |
The Company has recorded a valuation allowance for its deferred tax assets that it does not believe will be realizable at a more likely than not level based on analysis of all available sources of taxable income.
As of December 31, 2023 and 2022, the Company had federal net operating loss carryforwards of $195,676 and $174,736, respectively. As of December 31, 2023, the Company had state net operating loss carryforwards for New Jersey, California, Massachusetts, and Arizona of approximately $208,817, $4,912, $6,358, and $115, respectively. At December 31, 2022, the Company had state net operating loss carryforwards for New Jersey, California, Massachusetts and Arizona of approximately $169,847, $4,912, $5,277, and $46, respectively. Federal net operating loss carryforwards of $27,500 expire beginning in the year 2033. State net operating loss carryforwards begin to expire in the year 2033. Net operating loss carryforwards related to tax years after 2017 of$168,176 do not expire. The Company also has federal and state research and development credit carryforward of approximately $12,693 and $9,749 as of December 31, 2023 and 2022, respectively. The federal credits will begin to expire in 2034 if not utilized. The California state credits carryforward indefinitely and the New Jersey state credits expire starting in 2030. The above net operating losses and research and development credits are subject to
Sections 382 and 383 of the Internal Revenue Code. In the event of a change in ownership as defined by these code sections, the usage of the net operating losses and research and development credits may be limited.
The Company accrues interest and penalties related to unrecognized tax benefits in the (benefit) provision for income taxes line item in the consolidated statements of operations and comprehensive loss. As of December 31, 2023 and 2022, the Company hadnot accrued any interest or penalties related to uncertain tax positions.
If the ending balance of$3,173 and $2,437 of unrecognized tax benefits as of December 31, 2023 and 2022, respectively, were recognized, none of the recognition would affect the income tax rate. The following table summarized the activity related to the Company’s unrecognized tax benefits:
| For the Year Ended | ||
|---|---|---|
| December 31,2023 | December 31,2022 | |
| Unrecognized tax benefits, beginning of year | $2,437 | $1,654 |
| Increases related to prior year tax positions | - | - |
| Increases related to current year tax positions | 736 | 783 |
| Unrecognized tax benefits, end of year | $3,173 | $2,437 |
The Company does not anticipate any material change in its unrecognized tax benefits over the next twelve months. The unrecognized tax benefits may change during the next year for items that arise in the ordinary course of business.
The Company files U.S. federal and state income tax returns with varying statutes of limitations. The Company’s tax years 2013 to 2022 will remain open for examination by the federal and state authorities forthree andfour years, respectively, from the date of utilization of any net operating losses and research and development credits.
- Net Loss per Share
The Company excluded all outstanding stock options and restricted stock units at each period end from the computation of diluted net loss per share attributable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect. The following common stock equivalents were excluded from the calculation of diluted net loss per share:
| For the Years Ended December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Options to purchase common stock | 6,973,464 | 5,278,771 | 4,246,007 |
| Unvested restricted common stock units | 236,296 | 374,899 | — |
| Expected shares to be purchased under 2020 ESPP | 2,237 | 95,905 | 47,066 |
| Total | 7,211,997 | 5,749,575 | 4,293,073 |
- Related Parties
The Company has consulting agreements withtwo members of its board of directors; one of which waived his consulting fees starting as of September 2021. Total consulting fees paid during the years ended December 31, 2023, 2022, and 2021 were $92, $111, and $110, respectively. There wereno amounts owed under the consulting agreements as of December 31, 2023.
- Subsequent Events
On January 18, 2024, the Company announced a restructuring plan involving the reduction of its workforce by approximately 30% of the Company’s employees. The Company expects the reduction in workforce to be substantially completed by June 30, 2024, and fully completed by the end of the third quarter of 2024. The Company is taking these steps in order to streamline operations, reduce costs and preserve capital as it advances into late-stage development for its lead product candidate, PC14586.
As a result of the reduction in force, the Company expects to incur aggregate non-recurring charges between approximately $1.0 to $1.4 million, consisting primarily of employee severance and benefit costs associated with the restructuring. The Company expects that most of these charges will be cash expenditures and that it will recognize the majority of these charges in the first quarter of 2024.
The estimated charges that the Company expects to incur are subject to a number of assumptions, and actual expenses may differ materially from these estimates. The Company may also incur additional costs not currently contemplated due to unanticipated events that may occur as a result of, or that are associated with, its plan.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.