CalciMedica, Inc.
For the period ended Dec 31, 2024. Filed Mar 27, 2025.
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FY2024 · Filed Mar 27, 2025
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Notes to Consolidated Financial Statements
- Nature of Business
Description of Business
CalciMedica, Inc. (“CalciMedica” or the “Company”) (f/k/a Graybug Vision, Inc.) was incorporated in the state of Delaware in February 2015, following the conversion of Graybug, LLC, which was organized in May 2011, and has its principal operations in La Jolla, California. The Company is a clinical-stage biopharmaceutical company focused on developing therapeutics that treat serious illnesses driven by inflammatory processes and direct cellular damage. The Company had a wholly owned subsidiary, CalciMedica Subsidiary, Inc., incorporated in Delaware in October 2006, which survived the Merger as more fully described below. The CalciMedica Subsidiary entity was dissolved and combined with the Company as of December 31, 2024.
Reverse Merger Transaction
On March 20, 2023, Graybug Vision, Inc. (“Graybug”) completed a reverse merger transaction in accordance with the terms and conditions of the Agreement and Plan of Merger and Reorganization, dated as of November 21, 2022, as amended on February 10, 2023 (the “Merger Agreement”), by and among Graybug, Camaro Merger Sub, Inc., a wholly owned subsidiary of Graybug (“Merger Sub”), and CalciMedica, Inc. (“Private CalciMedica”), pursuant to which Merger Sub merged with and into Private CalciMedica, with Private CalciMedica surviving as a wholly owned subsidiary of Graybug (the “Merger”). Additionally, on March 20, 2023, Graybug changed its name from “Graybug Vision, Inc.” to “CalciMedica, Inc.” and Private CalciMedica changed its name from “CalciMedica, Inc.” to “CalciMedica Subsidiary, Inc.” At the completion of the Merger, the prior Private CalciMedica equity holders and the prior Graybug equity holders owned 72% and 28%, respectively of the combined company, in each case, on a fully diluted basis using the treasury stock method and excluding out-of-the-money options and warrants.
The Merger was accounted for as a reverse recapitalization, with Private CalciMedica being treated as the acquirer for accounting purposes. See discussions of the transactions in connection with the Merger in Note 3 - Merger and Related Transactions.
Liquidity
The Company has experienced net losses and negative cash flows from operating activities since its inception. The Company has an accumulated deficit of $159.8 million as of December 31, 2024, and a net loss of $13.7 million for the year ended December 31, 2024. Total operating expenses for the year ended December 31, 2024 were $24.2 million. Substantially all of the Company’s operating losses resulted from expenses incurred in connection with its research and development programs and from general and administrative costs associated with its operations.
The Company expects to incur significant expenses and increasing operating losses for the foreseeable future as the Company initiates and continues the preclinical and clinical development of its product candidates and adds personnel necessary to operate as a company with an advanced clinical pipeline of product candidates. The Company expects that its operating losses will fluctuate significantly from quarter-to-quarter and year-to-year due to timing of clinical development programs.
From inception to December 31, 2024, the Company has completed financings from the sale of preferred stock, warrants and common stock for total net proceeds of $140.7 million, including the 204 Private Placement and 2024 Follow-On described below, and has issued convertible debt for net proceeds of $8.6 million. In connection with the Merger, the Company received approximately $29.4 million of cash, cash equivalents and short-term investments. As of December 31, 2024, the Company had cash, cash equivalents and short-term investments of approximately $18.7 million. The Company closed the 2024 Private Placement (as defined in Note 7 below) on January 23, 2024 and the second closing of this private placement occurred on February 5, 2024. Gross proceeds from the transaction were $20.4 million with net proceeds of approximately $19.0 million after deducting $1.4 million in commissions and other transaction expenses. The Company closed a confidentially marketed public offering (the “2024 Follow On”) in October 2024 of the Company’s common stock for gross proceeds of $10.2 million and transaction costs of $0.9 million resulting in net proceeds of $9.3 million. On February 28, 2025, the Company entered into the (“Loan Agreement”) with Avenue Venture Opportunities Fund II, L.P. and Avenue Capital Management II, L.P. for an initial $10.0 million of gross proceeds (see Note 13).
The Company intends to seek additional funding through public and private financings, debt financings, collaboration agreements, strategic alliances and licensing agreements. Although the Company has been successful in raising capital in the past, there is no assurance of success in obtaining such additional financing on terms acceptable to us, it at all, and there is no assurance that the Company will be able to enter into collaborations or other arrangements. If the Company is unable to obtain funding when required or on acceptable terms, the Company may be required to scale back or discontinue the advancement of the product candidates, reduce headcount, file for bankruptcy, reorganize, merge with another entity or cease operations.
Based on the Company’s current operating plans, management believes its cash, cash equivalents, short-term investments and additional financing in February 2025, will be sufficient to fund its operations for the period of at least one year following the issuance of these financial statements.
- Summary of Significant Accounting Policies
Basis of Presentation and Principles of Consolidation
The consolidated financial statements have been prepared in conformity with U.S. generally accepted accounting principles (“U.S. GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”), and Accounting Standards Update (“ASU”), of the Financial Accounting Standards Board (“FASB”). The consolidated financial statements include the accounts of the Company for the year ended December 31, 2024 and the Company and CalciMedica Subsidiary, Inc. for the year ended December 31, 2023. All intercompany accounts and transactions have been eliminated in consolidation.
Since Private CalciMedica was determined to be the accounting acquirer in connection with the Merger, for periods prior to the Merger, the consolidated financial statements were prepared on a stand-alone basis for Private CalciMedica and did not include the combined entities activity or financial position. Subsequent to the Merger, the consolidated financial statements as of and for the year ended December 31, 2024 include Graybug’s activity from March 21, 2023 through December 31, 2024, and assets and liabilities at their acquisition date fair value. Historical share and per share figures of Private CalciMedica have been retroactively restated based on the merger exchange ratio of 0.0288.
Use of Estimates
The preparation of the Company’s consolidated financial statements requires management to make estimates and assumptions that impact the reported amounts of assets, liabilities and expenses and the disclosure of contingent assets and liabilities in the Company’s consolidated financial statements and accompanying notes. The most significant estimates in the Company’s consolidated financial statements relate to accruals for research and development expenses, valuation of warrants and valuation of equity awards. These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources. Actual results may differ materially and adversely from these estimates. To the extent there are material differences between the estimates and actual results, the Company’s future results of operations will be affected.
Concentration of Credit Risk and other Risks and Uncertainties
Financial instruments, which potentially subject the Company to concentration of risk, consist principally of cash and cash equivalents. The Company’s cash is deposited with major federally insured U.S. financial institutions. The Company has no off-balance sheet concentrations of credit risk, such as foreign currency exchange contracts, option contracts or other hedging arrangements.
The Company is dependent on contract manufacturing organizations (“CMO”) to supply products for research and development of its product candidates, including preclinical and clinical studies, and for commercialization of its product candidates, if approved. The Company’s development programs could be adversely affected by any significant interruption in CMO’s operations or by a significant interruption in the supply of active pharmaceutical ingredients and other components.
Products developed by the Company require approval from the FDA or other international regulatory agencies prior to commercial sales. There can be no assurance the Company’s product candidates will receive the necessary approvals. If the Company is denied approvals, approvals are delayed, or the Company is unable to maintain approvals received, such events could have a materially adverse impact on the Company.
Cash and Cash Equivalents
Cash and cash equivalents consist of readily available cash in checking accounts, money market funds and commercial paper. The Company considers all highly liquid investments with an original maturity of three months or less from the date of purchase to be cash equivalents.
Short-term Investments
The Company invests excess cash in commercial paper, U.S. treasury bills and U.S. government sponsored entities, such as mortgage-backed securities. These investments are included in short-term investments on the balance sheet, classified as available-for-sale and reported at fair value with unrealized gains and losses included in accumulated other comprehensive loss. Realized gains and losses on the sale of these securities are recognized in net loss.
Segment Information
The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. The financial information is regularly reviewed by the chief operating decision maker (“CODM”), in deciding how to allocate resources. The Company’s CODM is itschief executive officer. The Company’s singular focus is on developing highly selective calcium release-activated calcium channel inhibitors to improve outcomes for patients with acute inflammatory indications. No significant revenue has been generated since inception, and all tangible assets are held in the United States.
The Company operates asone operating segment focused on developing and commercializing innovative therapeutics primarily in the U.S. The accounting policies of the segment are the same as those described in the summary of significant accounting policies.
The determination of a single business segment is consistent with the consolidated financial information regularly reviewed by the chief executive officer, who is the Company's CODM, in assessing segment performance and deciding how to allocate resources on a consolidated basis.
The CODM makes decisions on resource allocation, assesses performance of the business, and monitors budget versus actual results using income from operations. Net loss is also a measure that is considered in monitoring budget versus actual results. The measure of segment assets is reported on the consolidated balance sheets as total consolidated assets.
The following table presents information about reported segment loss and significant segment expenses for the years ended December 31, 2024 and 2023:
| Years Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Segment research and development (a) (b) | $(13,607) | $(13,380) |
| Segment general and administrative (b) | (8,226) | (12,598) |
| Stock-based compensation (see Note 8) | (2,313) | (12,039) |
| Depreciation expense (see Note 2) | (58) | (58) |
| Operating loss | $(24,204) | $(38,075) |
| Reconciliation of profit or loss | ||
| Adjustments and reconciling items | — | — |
| Consolidated operating loss | $(24,204) | $(38,075) |
a)
Stock-based compensation expense of $840,000 and $2,449,000, related to research and development and $1,473,000 and $9,590,000, related to general and administration have been excluded for the years ended December 31, 2024 and 2023, respectively.
b)
Depreciation expense of $31,000 and $29,000, related to research and development and $28,000 and $28,000, related general and administration have been excluded for the years ended December 31, 2024 and 2023, respectively.
Fair Value Option
As permitted under ASC 825, Financial Instruments, the Company has elected the fair value option to account for its convertible promissory notes due to certain embedded features within the notes. The Company recognizes the convertible promissory notes at fair value with changes in fair value recognized in the consolidated statements of operations located on the change in fair value of financial instruments line item. Changes in fair value as a result of the Company’s own credit risk is reflected in other income in the consolidated statements of operations. As a result of applying the fair value option, direct costs and fees related to the convertible promissory notes were expensed as incurred and not deferred.
Leases
The Company leases office space with an original lease term oftwelve months and doesnot have a right-of-use asset or lease liability recorded. The Company's policy is not to record leases with an original term of twelve months or less on the consolidated balance sheets. The Company recognizes lease expense for this short-term lease on a straight-line basis over the term of the lease. The lease is accounted for under ASC 842, Leases, and has been classified as an operating lease. Rent expense recognized for the years ended December 31, 2024 and 2023 was $121,000 and $274,000, respectively.
Research and Development Costs
Research and development costs consist primarily of salaries, payroll taxes, employee benefits and stock-based compensation for those individuals involved in ongoing research and development efforts, as well as fees paid to consultants, external research fees, license fees paid to third parties for use of their intellectual property, laboratory supplies and development of compound materials, associated overhead expenses and facilities and depreciation costs. Nonrefundable advance payments for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have been received rather than when the payment is made. All research and development costs are expensed as incurred.
The Company estimates preclinical studies and clinical trial expenses based on the services performed pursuant to contracts with research institutions and clinical research organizations that conduct and manage preclinical studies and clinical trials on the Company’s behalf. In accruing service fees, the Company estimates the time period over which services will be performed and the level of effort to be expended in each period. These estimates are based on communications with the third-party service providers, and on information available at each balance sheet date. If the actual timing of the performance of services or the level of effort varies from the estimate, the Company will adjust the accrual accordingly. The estimates are trued up to reflect the best information available at the time of the financial statement issuance. Although the Company does not expect its estimates to be materially different from amounts actually incurred, the Company’s estimate of the status and timing of services performed relative to the actual status and timing of services performed may vary.
General and Administrative Costs
General and administrative expenses consist primarily of salaries and related benefits, including stock-based compensation, related to executive, finance, business development, legal, human resources and support functions, including professional fees for auditing, tax, consulting and patent-related services, rent and utilities and insurance.
Patent Costs
Costs related to filing and pursuing patent applications are expensed as incurred since recoverability of such expenditures is uncertain.
Deferred Offering Costs
The Company capitalizes costs that are directly associated with equity financings until such financings are consummated, at which time such costs are recorded against the gross proceeds of the offering. Should an in-process equity financing be abandoned, the deferred offering costs will be expensed immediately as a charge to operating expenses in the statements of operations and comprehensive loss. As of December 31, 2024, the Company had deferred costs associated with its ATM Facility (as defined in Note 7) and expensed these costs in the Company’s consolidated statement of operations.
Warrant Liability
Private CalciMedica has issued various freestanding warrants to purchase shares of its convertible preferred stock. Prior to the Merger, Private CalciMedica adjusted the carrying value of such convertible preferred stock warrants to the estimated fair value at each reporting date, with any related increases or decreases in the fair value being recorded within other income (expense) in the consolidated statements of operations and comprehensive loss. Pursuant to the Merger Agreement, the Series C convertible preferred stock warrants became warrants to purchase shares of the combined company's common stock. As a result of the Merger, the warrants no longer meet the requirements for liability accounting and, as such, Private CalciMedica adjusted the value of the warrants to the estimated fair value as of the Merger date and reclassified them to stockholders' equity (deficit).
As a result of the 2024 Private Placement, certain warrants to purchase common stock were deemed freestanding warrants and are reflected in the Company’s balance sheet as a liability as of and for the period ending December 31, 2024.
Stock-Based Compensation
Stock-based compensation expense represents the cost of the grant date fair value of employee stock options recognized over the requisite service period of the awards (usually the vesting period) on a straight-line basis. The Company estimates the fair value of stock option grants using the Black-Scholes option pricing model (“Black-Scholes”). Forfeitures are recognized as a reduction of stock-based compensation expense as they occur. Equity-based compensation expense is classified in the statements of operations in the same manner in which the award recipients’ payroll costs are classified or in which the award recipients’ service payments are classified. The fair value of each stock option grant is estimated on the date of grant using Black Scholes. The following summarizes the inputs used:
Fair Value of Common Stock
The Company uses the closing stock price the day prior to the grant date for the fair value.
Risk-Free Interest Rate
The risk-free interest rate is based on the U.S. Treasury yield in effect at the time of grant for zero coupon U.S. Treasury notes with maturities similar to the expected term of the awards.
Expected Volatility
The Company uses an average volatility for comparable publicly-traded biopharmaceutical companies over a period equal to the expected term of the stock award grant as CalciMedica does not yet have sufficient historical trading history for its own stock. CalciMedica will continue to apply this method until a sufficient amount of historical information over a period equal to the expected term of the stock-based awards becomes available.
Expected Term
The Company used the simplified method to calc ulate the expected term for all grants during all periods, which is based on the midpoint between the vesting date and the end of the contractual term.
Expected Dividend Yield
The Company has never paid and has no present intention to pay cash dividends.
Income Taxes
The Company accounts for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements. Under this method, deferred tax assets and liabilities are determined on the basis of the differences between the financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in income in the period that includes the enactment date.
The Company recognizes net deferred tax assets to the extent that the Company believes these assets are more likely than not to be realized. In making such a determination, management considers all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax-planning strategies, and results of recent operations. If management determines that the Company would be able to realize its deferred tax assets in the future in excess of their net recorded amount, management would make an adjustment to the deferred tax asset valuation allowance, which would reduce the provision for income taxes.
The Company records uncertain tax positions on the basis of a two-step process whereby (1) management determines whether it is more likely than not that the tax positions will be sustained on the basis of the technical merits of the position and (2) for those tax positions that meet the more-likely-than-not recognition threshold, management recognizes the largest amount of tax benefit that is more than 50% likely to be realized upon ultimate settlement with the related tax authority. The Company recognizes interest and penalties related to unrecognized tax benefits within income tax expense. Any accrued interest and penalties are included within the related tax liability.
Comprehensive Loss
Comprehensive loss is defined as a change in equity during a period from transactions and other events and circumstances from non-owner sources which are excluded from net loss. The Company’s only element of other comprehensive loss is unrealized gains and losses on marketable securities and short-term investments.
Related Party Transactions
The Company’s board of directors reviews and approves transactions with directors, officers and holders of 5% or more of its voting securities and their affiliates, each a related party. The material facts as to the related party’s relationship or interest in the transaction are disclosed to its board of directors prior to their consideration of such transaction, and the transaction is not considered approved by its board of directors unless a majority of the directors who are not interested in the transaction approve the transaction.
Beginning in November 2020, Private CalciMedica has paid consulting fees monthly to a consulting firm affiliated with the Company’s interim chief financial officer in connection with its consulting agreement. CalciMedica recorded expenseof $289,000 and $521,000 during years ended December 31, 2024 and 2023, respectively.
In May 2024, the Company granted a warrant to purchase 10,000 shares of common stock to a consulting firm affiliated with the Company’s interim chief financial officer. The Company recorded expense of$13,000 to general and administrative expense for the year ended December 31, 2024.
Net Loss Per Share
Net loss is equivalent to net loss attributable to common stockholders for all periods presented. Basic net loss per share is computed using the weighted average number of shares of common stock outstanding during the period. The Company calculates diluted net loss per share using the more dilutive of the (1) treasury stock method, if-converted method, or contingently issuable share method, as applicable, or (2) the two-class method. For warrants, the calculation of diluted net loss per share requires that, to the extent the average fair value of the underlying shares for the reporting period exceeds the exercise price of the warrants and the presumed exercise of such securities are dilutive to net loss per share for the period, adjustments to net loss used in the calculation are required to remove the change in fair value of the warrants for the period.
In all periods presented, the Company’s outstanding preferred stock, stock options, preferred, common and convertible promissory note warrants, and outstanding convertible promissory notes were excluded from the calculation of loss per share because the effect would be antidilutive. Accordingly, in periods in which the Company reports a net loss, diluted net loss per share is the same as basic net loss per share.
Recently Adopted Accounting Pronouncements
In August 2020, the FASB issued ASU 2020-06, Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40). The ASU provides guidance that simplified the accounting for certain financial instruments with characteristics of liabilities and equity. The new guidance reduced the number of accounting models for convertible debt and convertible preferred stock instruments and made certain disclosure amendments intended to improve the information provided to users. The guidance also amended the derivative guidance for the “own stock” scope exception, which exempts qualifying instruments from being accounted for as derivatives if certain criteria are met. Finally, the standard changed the way certain convertible instruments are treated when calculating earnings per share. This guidance is effective for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years, with early adoption permitted. The Company adopted this ASU as of January 1, 2024, which did not have a material impact on its consolidated financial statements and related disclosures.
In November 2023, the FASB issued ASU 2023-07 Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. This guidance expands public entities’ segment disclosures primarily by requiring disclosure of significant segment expenses that are regularly provided to the chief operating decision maker and included within each reported measure of segment profit or loss, an amount and description of its composition for other segment items, and interim disclosures of a reportable segment’s profit or loss and assets. The amendments are required to be applied retrospectively to all prior periods presented in an entity’s financial statements. The Company adopted the new accounting standard retrospectively for the fiscal year 2024. The adoption of this guidance did not have a material impact on the Company’s consolidated financial statements related disclosures, however, we have added additional footnote disclosure as part of the adoption.
In December 2023, the FASB issued final guidance in ASU No. 2023-09, Income Taxes (ASC 740): Improvements to Income Tax Disclosures requiring entities to provide additional information in the rate reconciliation and disclosures about income taxes paid. For public business entities, the guidance is effective for annual periods beginning after December 15, 2024. The Company has adopted this ASU No. 2023-09 effective December 31, 2024.
Recently Issued Accounting Pronouncements
In November 2024, the FASB issued ASU No. 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40) which requires public entities to disclose in the notes to financial statements, of additional specified information about certain costs and expenses. For public business entities, the guidance is effective for annual periods beginning after December 15, 2026 and interim periods after December 15, 2027, with early adoption permitted. The Company is currently assessing the impact that this guidance will have on the consolidated financial statements.
- Merger and Related Transactions
As described in Note 1 - Nature of Business, Private CalciMedica merged with a wholly-owned subsidiary of Graybug on March 20, 2023. The Merger was accounted for as a reverse recapitalization under U.S. GAAP. Private CalciMedica was considered the accounting acquirer for financial reporting purposes. This determination is based on the facts that, immediately following the Merger: (i) former Private CalciMedica stockholders owned a substantial majority of the voting rights of the combined company; Private CalciMedica designated a majority (five of seven) of the initial members of the board of directors of the combined company; and former Private CalciMedica's senior management held all key positions in senior management of the combined company. The transaction is accounted for as a reverse recapitalization of Graybug by Private CalciMedica similar to the issuance of equity for the net assets of Graybug, which are primarily cash and cash equivalents, short-term investments and other non-operating assets. It was concluded that any in-process research and development assets that remained as of the Merger would be de minimis when compared to the cash, cash equivalents and short-term investments obtained through the Merger.
Under reverse recapitalization accounting, the assets and liabilities of Graybug were recorded at their fair value, which approximated book value due to the short-term nature of the instruments. The Company's consolidated financial statements reflect the issuance of 1,571,433 shares to the former stockholders of Graybug.
Under the terms of the Merger Agreement, immediately prior to the effective time of the Merger, each outstanding share of Private CalciMedica capital stock (after giving effect to the automatic conversion of all shares of Private CalciMedica preferred stock into shares of Private CalciMedica common stock, the automatic exercise of certain Private CalciMedica warrants to purchase shares of Private CalciMedica common stock in accordance with their terms (the “Private CalciMedica warrant exercises”), the conversion of Private CalciMedica convertible promissory notes into Private CalciMedica common stock and the closing of the 2023 Private Placement (as defined and discussed in Note 7 - Convertible Preferred Stock, Common Stock, and Stockholders' Equity (Deficit)), was converted into the right to receive 0.0288 shares of Graybug common stock, which resulted in the issuance by Graybug of an aggregate of 3,946,540 shares of Graybug common stock to the stockholders of Private CalciMedica in a transaction exempt from registration under the Securities Act of 1933, as amended (the “Securities Act”), in reliance on Section 4(a)(2) of the Securities Act and the rules promulgated thereunder. In addition, Graybug assumed the Private CalciMedica 2006 Stock Plan (See Note 8 - Stock-Based Compensation), and each outstanding and unexercised option to purchase Private CalciMedica common stock and each outstanding and unexercised warrant to purchase Private CalciMedica common stock (excluding the warrants which were automatically exercised pursuant to the Private CalciMedica warrant exercises) became options and warrants, respectively, to purchase shares of Graybug common stock. Immediately following the consummation of the Merger prior Private CalciMedica and Graybug stockholders collectively own approximately 72% and 28% of the Company, respectively, on a fully diluted basis.
As part of the reverse recapitalization, Private CalciMedica received $29.4 million of cash, cash equivalents and short-term investments, net of transaction costs. Private CalciMedica also obtained prepaid and other current assets of approximately $2.1 million and assumed payables and accrued expenses of approximately $2.3 million. Private CalciMedica also incurred transaction costs of approximately $4.6 million, which is recorded as a reduction to additional paid-in capital in the accompanying consolidated statement of convertible preferred stock and stockholders' equity (deficit). The Company also recorded one-time charges of $10.5 million for the acceleration of the Graybug stock awards and $5.7 million in severance charges that are recorded in the consolidated statements of operations and comprehensive loss for the for the year ended December 31, 2023.
On March 17, 2023, in connection with the transactions contemplated by the Merger Agreement and following a special meeting of Graybug’s stockholders, Graybug filed an Amended and Restated Certificate of Incorporation effecting a reverse stock split of Graybug’s common stock, par value $0.0001 per share, at a ratio of 14:1.
- Fair Value Measurements
The Company's assets and liabilities which are measured at fair value include short-term investments and warrants for common stock. The Warrants for preferred stock (“Preferred Warrants”) and warrants for common stock related to the convertible promissory notes (“Convertible Promissory Note Warrants”) were all accounted for at fair value prior to the Merger (see Note 7 -
Convertible Preferred Stock, Common Stock and Stockholders’ Equity). All assets and liabilities recorded at fair value are revalued at each measurement period.
The Common Warrants (as defined in Note 7 below) were valued using Black-Scholes utilizing the following inputs; (i) a risk-free interest rate; (ii) volatility based on the expected term of the Common Warrant; (iii) and an exercise price and stock price on the date of the transaction. Several different scenarios were considered, and probability weighted to arrive at the final valuation. Increases or decreases in the fair value of the Common Warrants can result from updates to assumptions such as the expected timing or probability of the different settlement scenarios. Judgment is used in determining these assumptions as of the initial valuation date and at each subsequent reporting period. Updates to assumptions could have a significant impact on our results of operations in any given period.
The Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. The Company determines fair value based on assumptions that market participants would use in pricing an asset or liability in the principal or most advantageous market. When considering market participant assumptions in fair value measurements, the following fair value hierarchy distinguishes between observable and unobservable inputs, which are categorized in one of the following three levels:
Level 1: Observable inputs such as unadjusted quoted prices in active markets for identical assets or liabilities at the measurement date.
Level 2: Inputs (other than quoted prices included in Level 1) that are either directly or indirectly observable for the asset or liability. These include quoted prices for similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active.
Level 3: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.
The following tables present information about the Company’s financial assets measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values (in thousands):
| Level 1 | Level 2 | Level 3 | Total | |
|---|---|---|---|---|
| Current assets: | ||||
| Cash equivalents: | ||||
| Money market funds | $6,117 | $— | $— | $6,117 |
| Commercial paper | — | 746 | — | 746 |
| U.S. Treasury bills | — | 749 | — | 749 |
| Total cash equivalents | 6,117 | 1,495 | — | 7,612 |
| Short-term investments: | ||||
| Commercial paper | — | 6,573 | — | 6,573 |
| U.S. Treasury bills | — | 3,227 | — | 3,227 |
| U.S. Government sponsored entities - mortgage backed securities | — | 934 | — | 934 |
| Total short-term investments | — | 10,734 | — | 10,734 |
| Total assets measured at fair value | $6,117 | $12,229 | $— | $18,346 |
| Level 1 | Level 2 | Level 3 | Total | |
|---|---|---|---|---|
| Current assets: | ||||
| Cash equivalents: | ||||
| Money market funds | $3,634 | $— | $— | $3,634 |
| Commercial paper | — | 1,738 | — | 1,738 |
| Total cash equivalents | 3,634 | 1,738 | — | 5,372 |
| Short-term investments: | ||||
| Commercial paper | — | 5,213 | — | 5,213 |
| U.S. Government sponsored entities - mortgage-backed securities | — | 495 | — | 495 |
| Total short-term investments | — | 5,708 | — | 5,708 |
| Total assets measured at fair value | $3,634 | $7,446 | $— | $11,080 |
Money market funds are highly liquid investments which are actively traded. The pricing information on the Company’s money market funds is based on quoted prices in active markets for identical securities. This approach results in the classification of these securities as Level 1 of the fair value hierarchy.
Commercial paper and U.S. Government sponsored entities - mortgage-backed are classified as Level 2 with in the hierarchy and are carried at fair value with unrealized gains and losses included in other comprehensive income (loss) as a component of stockholders’ equity until realized. The Company estimates the fair values of these securities by taking into consideration valuations obtained from third-party pricing sources.
During the year ended December 31, 2024, there were no transfers between Level 1, Level 2 and Level 3.
The following tables present information about the Company’s financial liabilities measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values (in thousands):
| Level 1 | Level 2 | Level 3 | Total | |
|---|---|---|---|---|
| Liabilities: | ||||
| Warrant Liability | $— | $— | $1,700 | $1,700 |
| Total liabilities measured at fair value | $— | $— | $1,700 | $1,700 |
No fair value liabilities existed as of December 31, 2023.
The following provides a reconciliation for all liabilities measured at fair value using Level 3 inputs for the year ended December 31, 2024 (in thousands):
| Warrant liability | |
|---|---|
| Balance at December 31, 2023 | $— |
| Initial Fair Value of Warrants | 11,190 |
| Forfeiture of warrants | (200) |
| Change in Fair Value of Preferred Warrants | (9,290) |
| Balance at December 31, 2024 | $1,700 |
The following table presents information as to cost, unrealized gains and losses and fair value determination of the Company’s financial assets measured at fair value on a recurring basis (in thousands):
| AmortizedCost | UnrealizedGains | UnrealizedLosses | AggregateFair Value | |
|---|---|---|---|---|
| Current assets: | ||||
| Cash equivalents: | ||||
| Money market funds | $6,117 | $— | $— | $6,117 |
| Commercial paper | 746 | — | — | 746 |
| U.S Treasury bills | 749 | — | — | 749 |
| Total cash equivalents | 7,612 | — | — | 7,612 |
| Short-term investments: | ||||
| Commercial paper | 6,571 | 2 | — | 6,573 |
| U.S Treasury bills | 3,225 | 2 | — | 3,227 |
| U.S. Government sponsored entities - mortgage-backed securities | 934 | — | — | 934 |
| Total short-term investments | 10,730 | 4 | — | 10,734 |
| Total assets measured at fair value | $18,342 | $4 | $— | $18,346 |
As of December 31, 2024, the contractual maturities of all available-for-sale investments were less than 12 months. The Company periodically reviews the available-for-sale for other-than-temporary impairment loss. The Company had short-term investments in unrealized gain positions as of December 31, 2024.
| AmortizedCost | UnrealizedGains | UnrealizedLosses | AggregateFair Value | |
|---|---|---|---|---|
| Current assets: | ||||
| Cash equivalents: | ||||
| Money market funds | $3,634 | $— | $— | $3,634 |
| Commercial paper | 1,738 | — | — | 1,738 |
| Total cash equivalents | 5,372 | — | — | 5,372 |
| Short-term investments: | ||||
| Commercial paper | 5,211 | 2 | — | 5,213 |
| U.S Government sponsored entities - mortgage backed securities | 495 | — | — | 495 |
| Total short-term investments | 5,706 | 2 | — | 5,708 |
| Total assets measured at fair value | $11,078 | $2 | $— | $11,080 |
As of December 31, 2023, the contractual maturities of all available-for-sale investments were less than 12 months. The Company periodically reviews the available-for-sale for other-than-temporary impairment loss. The Company had short-term investments in unrealized gain positions as of December 31, 2023.
- Convertible Promissory Notes and Convertible Promissory Note Warrants
In April 2022, the Private CalciMedica board of directors approved a convertible promissory note financing pursuant to which it could issue and sell up to $5.0 million of notes convertible into shares of common stock (the “convertible promissory notes”) and Convertible Promissory Note Warrants. The funding and issuance of the convertible promissory notes for gross proceeds of $3.5 million and Convertible Promissory Note Warrants to purchase shares of the Private CalciMedica’s common stock at an exercise price of $0.01 per share took place in multiple closings through October 2022.
In November 2022, the Private CalciMedica board of directors amended the convertible promissory notes and Convertible Promissory Note Warrants to issue up to an additional $3.5 million (for a total of up to $8.5 million) and added the automatic conversion for a “de-SPAC” business combination or reverse merger transaction. In November 2022, Private CalciMedica issued additional convertible promissory notes for gross proceeds of $5.0 million and Convertible Promissory Note Warrants to purchase shares of Private CalciMedica’s common stock at an exercise price of $0.01 per share. The convertible promissory notes accrued interest at a rate of 6% per annum and had a maturity date of December 31, 2023. Immediately prior to the effective time of the Merger, all outstanding convertible promissory notes and unpaid and accrued interest automatically converted into 20,487,104 shares of Private CalciMedica’s common stock ata conversion price based on the equivalent valuation of the cash price paid per share by the private placement investors purchasing shares of common stock in the private placement multiplied by 0.85. Such shares of common stock were then converted into 590,031 shares of Graybug common stock at the effective time of the Merger in accordance with the Merger Agreement.
In connection with each purchase of a convertible promissory note, Private CalciMedica issued to each holder of such convertible promissory note Convertible Promissory Note Warrant to purchase shares of the Private CalciMedica’s common stock at an exercise price of $0.01 per share. Each holder of the Convertible Promissory Note Warrants had the right to purchase up to a number of shares of Private CalciMedica’s common stock equal to (i)15% (“Warrant Coverage”) of the principal amount of the convertible promissory note purchased by such holder concurrently therewith, divided by (ii) the cash price paid per share by the investors in the qualified financing or an initial public offering, as applicable, or in the case of a “de-SPAC” business combination or a reverse merger transaction between Private CalciMedica and a publicly traded company (a “Public Combination”), the equivalent valuation of the lower of the cash price per share by the investors purchasing shares in the publicly traded company in connection with such Public Combination or the cash price per shares by the investors purchasing shares of Private CalciMedica’s common stock in connection with such Public Combination, in each case, rounding down to the nearest whole share and subject to the terms of the convertible promissory notes; provided, however, that any holder that purchased convertible promissory notes in excess of the holder’s pro rata commitment (as defined in the convertible promissory notes) received a 40% Warrant Coverage on the principal amount of the convertible promissory notes that is in excess of its pro rata commitment. The Convertible Promissory Note Warrants had a five-year term. In connection with the Merger, the Convertible Promissory Note Warrants were automatically net exercised in accordance with the terms of the Convertible Promissory Note Warrants. Immediately prior to the effective time of the Merger,5,308,047 Convertible Promissory Note Warrants were converted into 5,308,047 shares of Private CalciMedica's common stock, which were converted into 152,875 shares of Graybug's common stock, based on the principal amount of the convertible promissory note.
Prior to the Merger, the Convertible Promissory Note Warrants were not deemed equity and were classified as a liability on the balance sheets. The Convertible Promissory Note Warrants were valued using a series of Monte Carlo simulations and Black-Scholes to determine the fair value, probability weighted for difference scenarios. The Monte Carlo simulations determined the liquidity event price. The Black-Scholes warrant value is discounted from the respective event date using the risk-free rate. The Black-Scholes valuation included standard assumptions such as exercise price, expected term, risk-free rate, volatility, and a dividend yield of zero. The Company estimated initial fair value of the Convertible Promissory Note Warrants utilizing the following range of assumptions for the difference scenarios: exercise price ($0.01), risk-free rate (3.02% -4.20%), volatility (63% -67%), andexpected term (4.1 -4.6 years). As of the date of the Merger, the Convertible Promissory Note Warrants which were converted into 152,871 shares of common stock were revalued, using the price of the common stock of Graybug of $5.50.
- Accrued Expenses
Accrued expenses consisted of the following (in thousands):
| December 31,2024 | December 31,2023 | |
|---|---|---|
| Accrued payroll and other employee benefits | $531 | $935 |
| Accrued severance | — | 89 |
| Accrued professional fees | 286 | 345 |
| Accrued other | 49 | 99 |
| Total accrued expenses | $866 | $1,468 |
- Convertible Preferred Stock, Common Stock and Stockholders' Deficit
Authorized Shares
The Company's current Amended and Restated Certificate of Incorporation authorizes 500,000,000 shares of common stock, par value $0.0001 per share, and 10,000,000 shares of preferred stock, par value $0.0001 per share.
Convertible Preferred Stock
Immediately prior to the effective time of the Merger, the 84,820,880 shares of Private CalciMedica preferred stock were converted into 84,820,880 outstanding shares of Private CalciMedica's common stock to be exchanged for 2,442,852 shares of Graybug's common stock.
Common Stock
Upon completion of the Merger on March 20, 2023, as the accounting acquirer, Private CalciMedica is deemed to have issued 1,571,433 shares of its common stock to Graybug shareholders.
Private Placement of Common Stock
Immediately prior to the consummation of the Merger, Private CalciMedica completed a private placement financing pursuant to which certain investors purchased approximately 20.7 million shares of Private CalciMedica’s common stock (the “2023 Private Placement”) for gross proceeds of approximately $10.3 million. In conjunction with the Merger, immediately prior to the effective time of the Merger,20,706,997 shares of Private CalciMedica common stock were converted into 596,363 shares of Graybug’s common stock.
On January 19, 2024, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with certain accredited investors, in which the Company sold the following securities to the accredited investors in a private placement transaction (the “2024 Private Placement”): (i) an aggregate of 4,985,610 shares of common stock; (ii) to certain investors, in lieu of shares of common stock, pre-funded warrants (the “Pre-Funded Warrants”) to purchase an aggregate of 306,506 shares of common stock and exercisable at any time; (iii) Tranche A Common Warrants (the “Tranche A Common Warrants”) to purchase an aggregate of up to 2,646,058 shares of common stock (or Pre-Funded Warrants in lieu thereof and, in such case, shares of common stock issuable upon exercise of such Pre-Funded Warrants); and (iv) Tranche B Common Warrants (the “Tranche B Common Warrants” and together with the Tranche A Common Warrants, the “Common Warrants”) to purchase an aggregate of up to 2,646,058 shares of common stock (or Pre-Funded Warrants in lieu thereof and, in such case, shares of common stock issuable upon exercise of such Pre-Funded Warrants). At date of issuance, the fair value of the common stock was $8.5 million using the relative fair value method and is included in equity at December 31, 2024.
The Company issued placement agent warrants (“Placement Agent Warrants”) to purchase 67,908 shares of common stock at the initial closing of the 2024 Private Placement and 7,839 shares of common stock at the second closing of the 2024 Private Placement, at an exercise price of $0.0001 per share. Each Placement Agent Warrant was accompanied by one Tranche A Common Warrant to purchase one half of a share of common stock and one Tranche B Warrant to purchase one half of a share of common stock, for an aggregate of 75,746 Common Warrants.
The initial closing of the 2024 Private Placement occurred on January 23, 2024 and the second closing occurred on February 5, 2024. Gross proceeds from the transaction were $20.4 million with net proceeds of approximately $19.0 million after deducting $1.4 million in commissions and other transaction costs. The Tranche A Common Warrants expired unexercised on July 29, 2024.
Underwritten Public Offering
On November 1, 2024, the Company closed an underwritten public offering of 2,720,000 shares of its common stock at a price to the public of $3.75 per share (the “2024 Follow-On”). The gross proceeds from the offering, before deducting underwriting discounts and commissions and offering expenses, were $10.2 million. In addition, the Company granted the underwriters a 30-day optionto purchase up to an additional 408,000 shares of its common stock at the public offering price, less underwriting discounts and commissions, which option expired unexercised.
Shelf Registration Statement and At the Market Offering
In August 2023, the Company filed a shelf registration statement on Form S-3 (the “Shelf Registration Statement”). The Shelf Registration Statement permits the offering, issuance and sale of common stock, preferred stock, debt securities and warrants having an aggregate offering price of up to $100.0 million in one or more offerings and in any combination of the foregoing.
The Shelf Registration Statement contains two prospectuses, a base prospectus and an at-the-market offering prospectus, as supplemented on March 29, 2024 (as supplemented, the “Original Prospectus Supplement”), that covered the offering, issuance and sale of up to $17.3 million of common stock pursuant to an at-the-market offering agreement (“ATM Agreement”) with H.C Wainwright & Co., LLC (“Wainwright”), acting as sales agent (“ATM Facility”).
On November 1, 2024, the Company closed the 2024 Follow-On and sold 2,720,000 shares of its common stock at a price to the public of $3.75 per share pursuant to the Shelf Registration Statement. The gross proceeds from the offering, before deducting underwriting discounts and commissions and offering expenses, were $10.2 million.
In connection with the 2024 Follow-on, on October 30, 2024, the Company suspended sales of common stock under the ATM Facility pursuant to the Original Prospectus Supplement, and until December 20, 2024, did not offer for sale any shares of common stock. The Company filed a prospectus supplement (the “Current Prospectus Supplement”) with the SEC on December 20, 2024 for an aggregate gross sales price of up to $4,450,000 of shares of common stock to be sold pursuant to the ATM Facility.
The Company intends to use the net proceeds from the ATM Facility for general corporate purposes, which may include research and development expenses, clinical trial expenses, capital expenditures and working capital. The ATM Facility will terminate upon the earlier of (i) the sale of all of the shares of our common stock provided for in the at the market offering prospectus or (ii) termination of the ATM Agreement as permitted therein. The ATM Agreement may be terminated at any time by either party upon written notice. During the year ended December 31, 2024, there were 8,950 shares sold under the ATM Facility. As of December 31, 2024, the Company has sold 101,522 shares of common stock for net proceeds of $319,000, after deducting $13,000 of commissions and settlement expenses paid under the ATM Facility and approximately $4.5 million remains available for sale under the ATM Facility. As of December 31, 2024, $89.5 million remains available for sale under the Shelf Registration Statement.
Preferred and Common Stock Warrants
The Company recognized a change in fair value of the Preferred Stock Warrants for each of the years ended December 31, 2024 and 2023 of $0 and $795,000, respectively. The change in fair value for the year ended December 31, 2023 was due to the conversion of Preferred Warrants to common stock warrants as part of the Merger.
In November 2020, Private CalciMedica granted a warrant to purchase 400,000 shares of common stock to a consulting firm affiliated with its former interim chief financial officer in connection with its consulting agreement. The warrant has a 10-year term, an exercise price of $0.19, and vests ratably over 24 months commencing on the effective date. At the date of issuance, the fair value of the warrant was determined to be $120,000, utilizing Black-Scholes with the following assumptions: expected term often years, risk-free rate of 0.96%, volatility of 80.0% and a dividend yield ofzero, which has been recognized as general and administrative expense over the vesting period. In conjunction with the Merger, the warrant converted to 11,520 warrants of CalciMedica at an exercise price of $6.60.
In October 2022, Private CalciMedica granted warrants to certain officers and directors to purchase 496,970 shares of common stock. In conjunction with the Merger, the warrants converted to 14,313 warrants of CalciMedica at an exercise price of $10.42. The warrants have a 10-year term and vest ratably over 12 and 48 months. At the date of issuance, the fair value of the warrants collectively was $125,000 and was determined utilizing Black-Scholes and will be recognized as general and administrative expense over the vesting periods. Assumptions used in the valuation were as follows: expected term often years, risk free rate of 4.10%, volatility of 82% and a dividend yield ofzero. The warrants are classified as equity, and the Company expensed $6,000 and $90,000 to general and administrative expense for the years ended December 31, 2024 and 2023, respectively.
In connection with the 2024 Private Placement, the Company issued Tranche A Common Warrants, Tranche B Common Warrants and Pre-Funded Warrants. Tranche A Common Warrants were exercisable until July 29, 2024. The Tranche B Common Warrants are exercisable upon the earlier of December 31, 2026 or 30 days following the Company’s public disclosure of topline results from the Company’s planned Phase 2 clinical trial in patients with acute kidney injury. The purchase price per share and accompanying Common Warrants was $3.827 (or $4.3915 for directors, employees or consultants of the Company participating in the 2024 Private Placement) (or $3.8269 per Pre-Funded Warrant and accompanying Common Warrants, which represented the price of $3.827 per share and accompanying Common Warrants minus the $0.0001 per share exercise price of each such Pre-Funded Warrant).
The Tranche A Common Warrants had a strike price of $5.36 per share, were not deemed equity and were classified as a liability in the Company’s condensed consolidated balance sheets. At the date of issuance, the fair value of the Tranche A Common Warrants was $4.1 million utilizing Black-Scholes with the following assumptions: expected term of 0.94 years, risk-free interest rate of 4.9%, volatility of 100% and a dividend yield ofzero. As of the balance sheet date of December 31, 2024, the value of the Tranche A Common Warrants wasnil with the change in fair value of $4.1 million for theyear ended December 31, 2024, respectively, being recorded in consolidated statements of operations in other income as the Tranche A Common Warrants expired unexercised on July 27, 2024.
The Tranche B Common Warrants have a strike price of $7.15 per share, are not deemed equity and are classified as a liability in the Company’s consolidated balance sheets. At the date of issuance, the fair value of the Tranche B Common Warrants was $7.1 million utilizing Black-Scholes with the following assumptions: expected term of 1.69 years, risk-free interest rate of 4.5%, volatility of 100% and a dividend yield ofzero. As of the balance sheet date of December 31, 2024, the value of the Tranche B Common Warrants was $3.4 million, with the change in fair value of $0.3 million and $3.7 million for the years ended December 31, 2024 and 2023, respectively, being recorded in the condensed consolidated statements of operations in other income.
The Pre-Funded Warrants have a strike price of $0.0001 per share, are deemed equity and included in the equity section of the Company’s consolidated balance sheets. At date of issuance, the fair value of the Pre-Funded Warrants was $0.5 million using the relative fair value method and is included in stockholders’ equity at December 31, 2024.
The Placement Agent Warrants have a strike price of $0.0001 per share, are deemed equity and included in the equity section of the Company’s consolidated balance sheets. At date of issuance, the fair value of the Placement Agent Warrants was $0.1 million using the relative fair value method and is included in equity at December 31, 2024.
In May 2024, the Company granted a warrant to a consulting firm affiliated with its chief financial officer to purchase 10,000 shares of common stock. At the date of issuance, the fair value of the warrant was $20,000 and was determined utilizing Black-Scholes and will be recognized as general and administrative expense over the vesting periods. Assumptions used in the valuation were as follows: expected term oftwelve months, risk free rate of 4.42%, volatility of 89% and a dividend yield ofzero. The warrant is classified as equity, and the Company expensed$13,000 to general and administrative expense for the year ended December 31, 2024.
- Stock-based Compensation
2023 Equity Incentive Plan
The Company adopted 2023 Equity Incentive Plan (the “2023 Plan”), which became effective at the closing of the Merger and replaced our 2020 Equity Incentive Plan (“2020 Plan”) on the effective date of the Merger. As of the effective date of the Merger, there were 1,000,000 shares of the Company’s common stock available for grant under the 2023 Plan. In addition, the share reserve is subject to annual increases each January 1 for the first ten years following approval of the 2023 Plan of up to 5% of shares of the Company’s common stock outstanding (or a lesser number determined by the Company’s board of directors). As of December 31, 2024,228,475 options have been returned of which 223,743 (granted under the 2020 Plan) are unavailable for future grant. Effective January 1, 2024, the shares reserved for issuance under the 2023 Plan was increased by 287,725 shares. Effective March 28, 2024, the Board approved an increase of 1,500,000 shares reserved under the 2023 Plan. This increase was subsequently approved by the stockholders of the Company on August 27, 2024. As of December 31, 2024,820,266 shares were available for grant under the 2023 Plan.
2023 Employee Stock Purchase Plan
The Company adopted the 2023 Employee Stock Purchase Plan (the “2023 ESPP”) which became effective at the closing of the Merger. As of the effective time of the Merger, there were 65,000 shares of the Company’s common stock reserved for issuance under the 2023 ESPP. In addition, the share reserve is subject to annual increases each January 1 for the first ten years following approval of the 2023 ESPP of the lesser of (i)1% of the total number of shares of the Company’s common stock outstanding on December 31 of the preceding calendar year, (ii)195,000 shares of the Company’s common stock, or (iii) such lesser number of shares of the Company’s common stock as determined by the Company’s board of directors. An annual increase of 57,545 shares of the Company’s common stock was automatically added to the share reserve under the 2023 ESPP on January 1, 2024.
As of December 31, 2024, no shares have been issued under the 2023 ESPP.
The following table summarizes the stock option transactions for the 2023 Plans:
| Total Options · Weighted Average Exercise Price · Weighted Average Remaining Contractual Term (years) · Aggregate Intrinsic Value (in thousands) | ||||||
|---|---|---|---|---|---|---|
| Outstanding at December 31, 2023 | 1,739,270 | $ | 15.71 | 6.99 | $ | 76 |
| Granted | 1,326,500 | 4.12 | 9.47 | 4 | ||
| Exercised | (12,852) | 1.55 | — | — | ||
| Cancelled | (228,475) | 75.27 | — | — | ||
| Outstanding at December 31, 2024 | 2,824,443 | $ | 5.51 | 8.15 | $ | 316 |
| Vested and exercisable at December 31, 2024 | 1,350,852 | $ | 6.46 | 7.09 | $ | 210 |
There were 12,852 options exercised and 1,326,500 options granted during the year ended December 31, 2024. The weighted-average fair value of options granted during the years ended December 31, 2024 and 2023 was $4.14 and $2.34 per share, respectively. The total fair value of shares vested was $5.0 million and $11.9 million (which includes $10.5 million related to the acceleration of vesting of the Graybug stock awards at the date of the Merger) for the year ended December 31, 2024 and December 31, 2023, respectively.
As of December 31, 2024, stock-based compensation not yet recognized is $4.7 million, which the Company expects to recognize over an estimated weighted-average term of 2.8 years.
The following is the range of underlying assumptions in Black-Scholes to determine the fair value of the stock option grants for the years ended December 31, 2024 and 2023:
| Year Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Risk free interest rate | 3.15% | 3.50%-3.56% |
| Expected volatility | 97% | 75%-76% |
| Expected term (years) | 6.01 | 6.25 |
| Expected dividend yield | 0% | 0% |
Restricted Stock Units (“RSU”)
The fair value of RSUs is determined on the date of grant based on the market price of the Company’s common stock on that date. The aggregate grant date fair value of RSUs vested during the year ended December 31, 2024 wasnil.
The following table summarizes restricted stock unit activity for the CalciMedica Plans:
| Number of Restricted Stock Units · Weighted Average Exercise Price | |||
|---|---|---|---|
| Outstanding at December 31, 2023 | — | $ | — |
| Granted | 40,000 | 3.50 | |
| Exercised | — | — | |
| Forfeited/Cancelled (expired) | — | — | |
| Outstanding at December 31, 2024 | 40,000 | $ | 3.50 |
| Vested and exercisable at December 31, 2024 | — | $ | — |
Stock-based Compensation Expense
Stock-based compensation expense recognized for options and restricted stock units granted was as follows (in thousands):
| Year Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Research and development | $840 | $2,449 |
| General and administrative | 1,473 | 9,590 |
| Total stock-based compensation expense | $2,313 | $12,039 |
The stock-based compensation expense for the year ended December 31, 2023, includes one-time charges for the acceleration of vesting of the Graybug stock options at the date of the Merger of $1.9 million and $8.6 million in research and development and general and administrative expenses, respectively.
Common Stock Reserved for Future Issuance
Common stock reserved for future issuance consists of the following at December 31, 2024:
| December 31, | |
|---|---|
| Common stock warrants | 3,352,621 |
| Stock options issued and outstanding | 2,824,443 |
| Shares available for issuance under the 2023 Plan | 807,414 |
| Shares available under the 2023 ESPP | 122,545 |
| Total | 7,107,023 |
- Commitments and 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 liabilities for such matters when future expenditures are probable and such expenditures can be reasonably estimated.
The Company has historically entered into contracts in the normal course of business with contract development and manufacturing organizations, for the manufacturing process development and the preclinical/clinical supply manufacturing, and its vendors for preclinical research studies and other services or products for operating purposes. These contracts generally provide for termination on notice of 60 to 90 days. As of December 31, 2024, there areseven such contracts, with one CMO related to its development of Auxora and one acquired as a result of the Merger with approximately $1.3 million and $1.2 million of associated costs, respectively, still in effect for future services, and there wereno unpaid cancellation or other related costs.
The Company may also, from time to time, become party or subject to various other legal proceedings and claims, either asserted or unasserted, which arise in the ordinary course of business. Some of these proceedings have involved, and may involve in the future, claims that are subject to substantial uncertainties and unascertainable damages.
Operating Lease Agreements
The Company has an operating lease for office space in La Jolla, California. In December 2024, an amendment wasexecuted for a twelve month term as of January 1, 2025 and therefore qualifies for the short-term lease exception. Since the lease was amended and renewed in December 2024 for an additional twelve month term it therefore qualifies for the short-term lease exception. Base rent for this lease is approximately $10,500 monthly.
Rent expense for the years ended December 31, 2024 and 2023 was $121,000 and $274,000, respectively, which is included in operating expenses.
- Employee Benefits
In January 2007, Private CalciMedica adopted a defined contribution 401(k) plan for substantially all employees. Contributions made by CalciMedica to the 401(k) plan were$0 and $78,000 for the years ended December 31, 2024 and 2023, respectively.
- Income Taxes
The effective tax rate if the Company’s provision (benefit) for income taxes differs from the federal statutory rate as follows (in thousands):
| Year Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Tax computed at federal statutory rate | $(2,877) | $(7,214) |
| State tax, net of federal tax benefit | 611 | 1 |
| Permanent differences | (166) | 50 |
| Warrant liability | (1,993) | (665) |
| Research and development tax credits, net of uncertain positions | (1,050) | (705) |
| Valuation allowance | 5,475 | 8,534 |
| Income tax expense | $— | $1 |
Deferred income taxes reflect the net tax effects of (a) temporary differences between the carrying amount of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes, and (b) operating losses and tax credit carryforwards. Significant components of deferred tax assets (liabilities) are as follows (in thousands):
| Year Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Deferred tax assets: | ||
| Net operating loss carryforwards | $62,407 | $58,535 |
| Intangible assets | 10,356 | 9,865 |
| Tax credit carry forwards | 13,506 | 12,403 |
| Stock compensation | 2,026 | 1,700 |
| Accrued compensation | 180 | 93 |
| Total deferred tax assets | 88,475 | 82,596 |
| Deferred tax liabilities | ||
| Fixed assets | (15) | (21) |
| Total deferred tax liabilities | (15) | (21) |
| Total net deferred tax assets | 88,460 | 82,575 |
| Less: valuation allowance | (88,460) | (82,575) |
| Net deferred taxes | $— | $— |
The Company provided a full valuation allowance on the net deferred tax asset because management has determined that it is more-likely-than-not that the Company will not earn income sufficient to realize the deferred tax assets during the carryforward period. As of December 31, 2024, the Company has federal and state NOLs available of approximately $296.9 million andnil, respectively, to offset future taxable income, if any, for federal and state income tax purposes. The federal and state NOLs expire beginning in 2026. The Company has $194.7 million of post-2017 federal NOL carryforwards that carry forward indefinitely. In addition, under the Tax Act the amount of net operating losses generated in taxable periods beginning after December 31, 2017, that the Company is permitted to deduct in any taxable year is limited to 80% of taxable income in such year, where taxable income is determined without regard to the net operating loss deduction itself. The Tax Act generally eliminates the ability to carry back any net operating loss to prior taxable years, while allowing post-2017 unused net operating losses to be carried forward indefinitely.
As of December 31, 2024, the Company has federal and state research and development credit carryforwards available of approximately $13.3 million and $3.1 million, respectively. Federal research and development carryforwards expire beginning in 2027. State research and development carryforwards do not expire.
Pursuant to Internal Revenue Code of 1986, as amended (the “Code”) specifically by IRC §382, the Company’s ability to use net operating loss carryforwards to offset future taxable income is limited if the Company experiences a cumulative change in ownership of more than 50% within a three-year testing period. The Company has not completed an ownership change analysis pursuant to IRC Section 382. If ownership changes within the meaning of IRC Section 382 are identified as having occurred, the amount of remaining tax attribute carryforwards available to offset future taxable income and income tax expense in future years may be significantly reduced. Any limitation may result in the expiration of a portion of the NOL carryforwards before utilization.
The change in the Company’s unrecognized tax benefits is summarized as follows (in thousands):
| Balance at December 31, 2022 | $7,506 |
|---|---|
| Increase related to current year tax positions | 2,846 |
| Additions for tax positions of prior years | 21 |
| Additions in connection with the reverse merger | 847 |
| Reduction for tax positions of prior years | (140) |
| Balance at December 31, 2023 | $11,080 |
| Increase related to current year tax positions | 334 |
| Additions for tax positions of prior years | 68 |
| Balance at December 31, 2024 | $11,482 |
The Company accounts for uncertainty in income taxes in accordance with ASC 740 Income Taxes. Tax positions are evaluated in a two-step process, whereby the Company first determines whether it is more likely than not that a tax position will be sustained upon examination by the tax authority, including resolutions of any related appeals or litigation processes, based on technical merit. If a tax position meets the more-likely-than-not recognition threshold it is then measured to determine the amount of benefit to recognize in the financial statements. The tax position is measured as the largest amount of benefit that is greater than 50% likely of being realized upon ultimate settlement.
The Company recognizes a tax benefit from an uncertain tax position when it is more likely than not that the position will be sustained upon examination, including resolutions of any related appeals or litigation processes, based on the technical merits. Income tax positions must meet a more likely than not recognition threshold to be recognized. The Company’s practice is to recognize interest and/or penalties related to income tax matters in income tax expense. The Company hadno accrual for interest and penalties and has not recognized interest and/ or penalties in the statements of operations and comprehensive loss for the years ended December 31, 2024 and 2023. Uncertain tax positions are evaluated based upon the facts and circumstances that exist at each reporting period. Subsequent changes in judgment based upon new information may lead to changes in recognition, derecognition, and measurement. Adjustments may result, for example, upon resolution of an issue with the taxing authorities or expiration of a statute of limitations barring an assessment for an issue.
As of December 31, 2024, and 2023, unrecognized tax benefits associated with uncertain tax positions was approximately $11.8 million and $9.1 million respectively. If recognized, this would affect the effective tax rate, subject to valuation allowance. As of December 31, 2024, the Company did not recognize any interest and penalties associated with unrecognized tax benefits. Due to net operating losses incurred, tax years from inception remain open to examination by the Federal and State taxing jurisdictions to which we are subject. The Company is not currently under Internal Revenue Services (IRS), state or local tax examination.
- Net Loss Per Share
The following table sets forth the computation of basic and diluted net loss per share (in thousands, except per share amounts):
| Year Ended December 31, | ||||
|---|---|---|---|---|
| 2024 · 2023 | ||||
| Numerator: | ||||
| Net loss | $ | (13,700) | $ | (34,357) |
| Denominator | ||||
| Basic and diluted | ||||
| Weighted-average common shares outstanding, basic and diluted | 10,886,920 | 4,486,258 | ||
| Weighted-average pre-funded warrants outstanding, basic and diluted | 288,082 | — | ||
| Weighted-average placement agent warrants outstanding, basic and diluted | 70,913 | — | ||
| Weighted-average number of shares used to calculate basic and diluted net loss per share | 11,245,915 | 4,486,258 | ||
| Net loss per share - basic and diluted | $ | (1.22) | $ | (7.66) |
The following outstanding potentially dilutive shares have been excluded from the calculation of diluted net loss per share due to their anti-dilutive effect:
| As of December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Stock options to purchase common stock | 2,824,443 | 1,739,747 |
| Warrants to purchase common stock | 2,970,368 | 276,437 |
| Total | 5,794,811 | 2,016,184 |
- Subsequent Events
Loan Agreement
On February 28, 2025 (the “Closing Date”), the Company the Loan Agreement with Avenue Venture Opportunities Fund II, L.P. (“Lender”) and Avenue Capital Management II, L.P., as administrative agent and collateral agent, for growth capital loans in an aggregate principal amount of up to $32,500,000 (the “Loan”), with (i) $10,000,000 funded on the Closing Date (“Tranche 1”), (ii) up to $7,500,000 to be made available to the Company between September 1, 2025 and March 31, 2026, subject to, among other things, the Company’s achievement of certain milestones with respect to certain of its ongoing clinical trials (“Tranche 2”) and (iii) up to $15,000,000 to be made available to the Company between October 1, 2025 and March 31, 2026, subject to, among other things, (a) the Company’s achievement of additional milestones with respect to certain of its ongoing clinical trials and (b) the mutual written agreement of the Company and the Lender (upon its investment committee approval). The Company will make interest only payments until the 18 month anniversary of the Closing Date, subject to a 6-month extension upon the Company’s achievement of certain milestones with respect to certain of its ongoing clinical trials and funding of the full amount under Tranche 2. The Loan bears interest at an annual rate equal to the greater of (a) the sum of 5.00% plus the prime rate as reported in The Wall Street Journal and (b)12.75%. The Loan is secured by a lien upon and security interest in all of the Company’s assets, including intellectual property, subject to agreed exceptions. The maturity date of the Loan is September 1, 2028 (the “Maturity Date”).
Warrant
In connection with the Loan, pursuant to the funding of Tranche 1 on the Closing Date, the Company issued to the Lender a warrant to purchase 641,163 shares of common stock of the Company (the “Warrant”) at an exercise price per share equal to $2.32 (the “Stock Purchase Price”). The Warrant is exercisable until February 28, 2030 (the “Expiration Date”) and upon a change of control, the Lender would be entitled to receive the shares of common stock underlying the Warrant without payment of the exercise price.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.