Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2023 | Nov. 03, 2023 | |
Document Information [Line Items] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2023 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
Entity Trading Symbol | VRCA | |
Entity Interactive Data Current | Yes | |
Entity Registrant Name | Verrica Pharmaceuticals Inc. | |
Entity Central Index Key | 0001660334 | |
Entity Current Reporting Status | Yes | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Common Stock, Shares Outstanding | 42,064,553 | |
Entity Shell Company | false | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transaction Period | true | |
Entity File Number | 001-38529 | |
Entity Tax Identification Number | 46-3137900 | |
Title of 12(b) Security | Common Stock, $0.0001 par value | |
Security Exchange Name | NASDAQ | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity Incorporation, State or Country Code | DE | |
Entity Address, Address Line One | 44 West Gay Street | |
Entity Address, Address Line Two | Suite 400 | |
Entity Address, City or Town | West Chester | |
Entity Address, State or Province | PA | |
Entity Address, Postal Zip Code | 19380 | |
City Area Code | 484 | |
Local Phone Number | 453-3300 |
CONDENSED BALANCE SHEETS
CONDENSED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 84,308 | $ 34,273 |
Accounts receivable | 3,946 | 0 |
Collaboration revenue receivable | 0 | 388 |
Unbilled revenue | 126 | 99 |
Inventory | 279 | 0 |
Prepaid expenses and other current assets | 3,066 | 4,355 |
Total current assets | 91,725 | 39,115 |
Property and equipment, net | 3,558 | 3,887 |
Operating lease right-of-use asset | 1,339 | 1,443 |
Other non-current assets | 526 | 276 |
Total assets | 97,148 | 44,721 |
Current liabilities: | ||
Accounts payable | 1,925 | 507 |
Accrued expenses and other current liabilities | 9,102 | 2,655 |
Operating lease liability | 316 | 297 |
Financing lease liability | 31 | 0 |
Total current liabilities | 11,374 | 3,459 |
Operating lease liability | 989 | 1,229 |
Finance lease liability | 81 | 0 |
Long term debt | 42,401 | 0 |
Total liabilities | 54,845 | 4,688 |
Commitments and Contingencies (Note 10) | ||
Stockholders’ equity: | ||
Preferred stock, $0.0001 par value; 10,000,000 shares authorized; no shares issued and outstanding as of September 30, 2023 and December 31, 2022 | 0 | 0 |
Common stock, $0.0001 par value; 200,000,000 authorized; 42,169,697 shares issued and 42,064,553 shares outstanding as of September 30, 2023 and 41,199,197 shares issued and 41,094,053 shares outstanding as of December 31, 2022 | 4 | 4 |
Treasury stock, at cost, 105,144 shares as of September 30, 2023 and December 31, 2022 | 0 | 0 |
Additional paid-in capital | 248,133 | 203,482 |
Accumulated deficit | (205,834) | (163,453) |
Total stockholders’ equity | 42,303 | 40,033 |
Total liabilities and stockholders’ equity | $ 97,148 | $ 44,721 |
CONDENSED BALANCE SHEETS (Paren
CONDENSED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 42,169,697 | 41,199,197 |
Common stock, shares outstanding | 42,064,553 | 41,094,053 |
Treasury Stock, Common, Shares | 105,144 | 105,144 |
CONDENSED STATEMENTS OF OPERATI
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Revenue: | ||||
Total revenue | $ 2,917 | $ 8,319 | $ 3,136 | $ 8,964 |
Operating expenses: | ||||
Selling, general and administrative | 20,054 | 3,925 | 30,310 | 14,216 |
Research and development | 6,510 | 2,780 | 14,975 | 9,170 |
Cost of product revenue | 145 | 0 | 145 | 0 |
Cost of collaboration revenue | 125 | 166 | 329 | 663 |
Total operating expenses | 26,834 | 6,871 | 45,759 | 24,049 |
(Loss) income from operations | (23,917) | 1,448 | (42,623) | (15,085) |
Other income (expense): | ||||
Interest income | 822 | 148 | 1,948 | 190 |
Interest expense | (1,657) | (81) | (1,657) | (2,172) |
Loss on extinguishment of debt | 0 | (1,437) | 0 | (1,437) |
Other (expense) income | (50) | 5 | (49) | (51) |
Total other (expense) income, net | (885) | (1,365) | 242 | (3,470) |
Net (loss) income | $ (24,802) | $ 83 | $ (42,381) | $ (18,555) |
Net (loss) income per share, basic | $ (0.54) | $ 0 | $ (0.94) | $ (0.58) |
Net (loss) income per share, diluted | $ (0.54) | $ 0 | $ (0.94) | $ (0.58) |
Weighted average common shares outstanding, basic | 46,073,932 | 40,304,923 | 45,015,900 | 31,827,844 |
Weighted average common shares outstanding, diluted | 46,073,932 | 40,321,639 | 45,015,900 | 31,827,844 |
Net (loss) Income | $ (24,802) | $ 83 | $ (42,381) | $ (18,555) |
Other comprehensive gain: | ||||
Unrealized gain on marketable securities | 0 | 35 | 0 | 0 |
Comprehensive (loss) income | (24,802) | 118 | (42,381) | (18,555) |
Product [Member] | ||||
Revenue: | ||||
Total revenue | 2,792 | 0 | 2,792 | 0 |
Collaboration Revenue [Member] | ||||
Revenue: | ||||
Total revenue | $ 125 | $ 8,319 | $ 344 | $ 8,964 |
CONDENSED STATEMENTS OF STOCKHO
CONDENSED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid-In Capital [Member] | Accumulated Deficit [Member] | Treasury Stock, Common [Member] | Accumulated Other Comprehensive Gain (Loss) [Member] |
Beginning Balance at Dec. 31, 2021 | $ 32,605 | $ 3 | $ 171,597 | $ (138,966) | $ (29) | |
Beginning Balance (shares) at Dec. 31, 2021 | 27,624,197 | 105,144 | ||||
Stock-based compensation | 1,316 | 1,316 | ||||
Net (loss) income | (8,470) | (8,470) | ||||
Unrealized gain (loss) on marketable securities | (33) | (33) | ||||
Ending Balance at Mar. 31, 2022 | 25,418 | $ 3 | 172,913 | (147,436) | (62) | |
Ending Balance (shares) at Mar. 31, 2022 | 27,624,197 | 105,144 | ||||
Beginning Balance at Dec. 31, 2021 | 32,605 | $ 3 | 171,597 | (138,966) | (29) | |
Beginning Balance (shares) at Dec. 31, 2021 | 27,624,197 | 105,144 | ||||
Net (loss) income | (18,555) | |||||
Unrealized gain (loss) on marketable securities | 0 | |||||
Ending Balance at Sep. 30, 2022 | 44,765 | $ 4 | 202,311 | (157,521) | (29) | |
Ending Balance (shares) at Sep. 30, 2022 | 41,199,197 | 105,144 | ||||
Beginning Balance at Mar. 31, 2022 | 25,418 | $ 3 | 172,913 | (147,436) | (62) | |
Beginning Balance (shares) at Mar. 31, 2022 | 27,624,197 | 105,144 | ||||
Stock-based compensation | 1,085 | 1,085 | ||||
Net (loss) income | (10,168) | (10,168) | ||||
Unrealized gain (loss) on marketable securities | (2) | (2) | ||||
Ending Balance at Jun. 30, 2022 | 16,333 | $ 3 | 173,998 | (157,604) | (64) | |
Ending Balance (shares) at Jun. 30, 2022 | 27,624,197 | 105,144 | ||||
Stock-based compensation | 1,413 | 1,413 | ||||
Issuance of common stock, net of issuance costs | 26,901 | $ 1 | 26,900 | |||
Issuance of common stock, net of issuance costs (shares) | 13,575,000 | |||||
Net (loss) income | 83 | 83 | ||||
Unrealized gain (loss) on marketable securities | 35 | 35 | ||||
Ending Balance at Sep. 30, 2022 | 44,765 | $ 4 | 202,311 | (157,521) | $ (29) | |
Ending Balance (shares) at Sep. 30, 2022 | 41,199,197 | 105,144 | ||||
Beginning Balance at Dec. 31, 2022 | 40,033 | $ 4 | 203,482 | (163,453) | ||
Beginning Balance (shares) at Dec. 31, 2022 | 41,199,197 | 105,144 | ||||
Stock-based compensation | 1,094 | 1,094 | ||||
Issuance of common stock and pre-funded warrants, for the purchase of common stock, net of issuance costs, Shares | 750,000 | |||||
Issuance of common stock and pre-funded warrants, for the purchase of common stock, net of issuance costs | 30,301 | 30,301 | ||||
Exercise of stock options | 7 | 7 | ||||
Exercise of stock options (shares) | 8,000 | |||||
Net (loss) income | (6,589) | (6,589) | ||||
Ending Balance at Mar. 31, 2023 | 64,846 | $ 4 | 234,884 | (170,042) | ||
Ending Balance (shares) at Mar. 31, 2023 | 41,957,197 | 105,144 | ||||
Beginning Balance at Dec. 31, 2022 | $ 40,033 | $ 4 | 203,482 | (163,453) | ||
Beginning Balance (shares) at Dec. 31, 2022 | 41,199,197 | 105,144 | ||||
Exercise of stock options (shares) | 8,000 | |||||
Net (loss) income | $ (42,381) | |||||
Unrealized gain (loss) on marketable securities | 0 | |||||
Ending Balance at Sep. 30, 2023 | 42,303 | $ 4 | 248,133 | (205,834) | ||
Ending Balance (shares) at Sep. 30, 2023 | 42,169,697 | 105,144 | ||||
Beginning Balance at Mar. 31, 2023 | 64,846 | $ 4 | 234,884 | (170,042) | ||
Beginning Balance (shares) at Mar. 31, 2023 | 41,957,197 | 105,144 | ||||
Stock-based compensation | 1,544 | 1,544 | ||||
Net (loss) income | (10,990) | (10,990) | ||||
Ending Balance at Jun. 30, 2023 | 55,400 | $ 4 | 236,428 | (181,032) | ||
Ending Balance (shares) at Jun. 30, 2023 | 41,957,197 | 105,144 | ||||
Stock-based compensation | 9,663 | 9,663 | ||||
Common stock warrants issued with debt | 2,041 | 2,041 | ||||
Vesting of restricted stock units | 212,500 | |||||
Net (loss) income | (24,802) | (24,802) | ||||
Unrealized gain (loss) on marketable securities | 0 | |||||
Ending Balance at Sep. 30, 2023 | $ 42,303 | $ 4 | $ 248,133 | $ (205,834) | ||
Ending Balance (shares) at Sep. 30, 2023 | 42,169,697 | 105,144 |
CONDENSED STATEMENTS OF CASH FL
CONDENSED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Cash flows from operating activities | |||||
Net loss | $ (42,381) | $ (18,555) | |||
Adjustments to reconcile net loss to net cash used in operating activities: | |||||
Stock-based compensation | $ 9,663 | $ 1,413 | 12,301 | 3,814 | |
Amortization of premiums on marketable securities | 0 | 97 | |||
Depreciation expense | 399 | 323 | |||
Noncash interest expense | 338 | 384 | |||
Loss on disposal of fixed assets | 61 | 0 | |||
Loss on extinguishment of debt | 0 | 1,437 | 0 | 1,437 | $ (1,400) |
Gain on operating lease termination | 0 | (6) | |||
Amortization in operating lease right-of-use asset | 220 | 194 | |||
Changes in operating assets and liabilities: | |||||
Prepaid expenses and other assets | 1,007 | 264 | |||
Accounts payable | 1,623 | (708) | |||
Accounts receivable | (3,946) | 0 | |||
Unbilled receivable | 361 | (419) | |||
Accrued expenses and other current liabilities | 6,171 | (327) | |||
Operating lease liability | (224) | (194) | |||
Net cash used in operating activities | (24,070) | (13,696) | |||
Cash flows from investing activities | |||||
Sales and maturities of marketable securities | 0 | 52,008 | |||
Purchases of marketable securities | 0 | (4,485) | |||
Purchases of property and equipment | (135) | (236) | |||
Net cash (used in) provided by investing activities | (135) | 47,287 | |||
Cash flows from financing activities | |||||
Proceeds from exercise of stock options | 7 | 0 | |||
Proceeds from issuance of debt, net of issuance costs | 44,105 | 0 | |||
Payment of equity issuance costs | (173) | 0 | |||
Repayment of debt | 0 | (43,750) | |||
Payment of debt issuance costs | 0 | (17) | |||
Repayment of financing lease | 0 | (4) | |||
Proceeds from issuance of common stock, net of issuance costs | 30,301 | 26,901 | |||
Net cash provided by (used in) financing activities | 74,240 | (16,870) | |||
Net increase in cash, cash equivalents and restricted cash | 50,035 | 16,721 | |||
Cash and cash equivalents at the beginning of the period | 34,273 | 15,752 | 15,752 | ||
Cash and cash equivalents at the end of the period | $ 84,308 | $ 32,473 | 84,308 | 32,473 | $ 34,273 |
Supplemental disclosure of noncash investing and financing activities: | |||||
Property and equipment purchases in accounts payable or accrued expenses and other current liabilities at period end | 93 | 291 | |||
Change in unrealized gain on marketable securities | 0 | 0 | |||
Cash paid for interest | 1,319 | 1,788 | |||
Common stock warrants issued with debt | 2,041 | 0 | |||
Right-of-use asset obtained in exchange for lease obligation | $ 116 | $ 99 |
Nature of Business
Nature of Business | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of Business | Note 1—Nature of Business Verrica Pharmaceuticals Inc. (the “Company”) was formed on July 3, 2013 and is incorporated in the State of Delaware. The Company is a dermatology therapeutics company developing and selling medications for skin diseases requiring medical intervention. On July 21, 2023, the U.S. Food and Drug Administration (“FDA”) approved YCANTH (VP-102) topical solution for the treatment of molluscum contagiosum in adult and pediatric patients two years of age and older. The Company launched commercial operations in August 2023. Liquidity The Company has incurred substantial operating losses since inception and expects to continue to incur significant operating losses for the foreseeable future and may never become profitable. As of September 30, 2023 , the Company had an accumulated deficit of $ 205.8 million. In February 2023, the Company closed an underwritten offering of 750,000 shares of its common stock and pre-funded warrants to purchase 4,064,814 shares of common stock. The shares of common stock were sold at a price of $ 6.75 per share and the pre-funded warrants were sold at a price of $ 6.7499 per pre-funded warrant resulting in net proceeds of $ 30.3 million after deducting underwriting discounts and commissions, and offering expenses of approximately $ 2.2 million (see Note 8). On July 26, 2023, the Company entered into a Credit Agreement which provides for up to $ 125.0 million in debt under a Loan Facility (as defined in Note 7). The Company borrowed $ 50.0 million under the Loan Facility on July 26, 2023, resulting in net proceeds of approximately $ 44.1 million after payment of certain fees and transaction related expenses. In addition, up to $ 25.0 million will be made available on or prior to June 30, 2024, up to $ 30.0 million will be made available on or prior to December 31, 2024, up to $ 10.0 million will be made available on or prior to March 31, 2025, and up to $ 10.0 million will be made available on or prior to June 30, 2025, in each case, subject to the Company's achievement of certain revenue targets. Amounts borrowed under the Loan Facility will mature on July 26, 2028 . In accordance with Accounting Standards Update, or ASU, No. 2014-15 , Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern , the Company has evaluated whether there are certain conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the financial statements are issued. The Company believes its cash and cash equivalents of $ 84.3 million as of September 30, 2023 will be sufficient to allow the Company to operate for a period greater than twelve months from the issuance date of these condensed financial statements and extend beyond the twelve months into the first quarter of 2025. |
Significant Accounting Policies
Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies | Note 2—Significant Accounting Policies Basis of Presentation The accompanying unaudited interim condensed financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”) as determined by the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) for interim financial information. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, the unaudited interim condensed financial statements reflect all adjustments, which include only normal recurring adjustments necessary for the fair statement of the balances and results for the periods presented. They may not include all of the information and footnotes required by GAAP for complete financial statements. Therefore, these financial statements should be read in conjunction with the Company’s audited financial statements and notes thereto for the year ended December 31, 2022 included in its Form 10-K, filed with the Securities and Exchange Commission (the “SEC”) on March 6, 2023. The results of operations for any interim periods are not necessarily indicative of the results that may be expected for the entire fiscal year or any other interim period. 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 the reported amounts of expenses during the reporting period. These estimates and assumptions are based on current facts, historical experience as well as other pertinent industry and regulatory authority information 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. Reclassifications Certain prior period amounts have been reclassified to conform with current period presentation. Collateral Cash Cash and cash equivalents at September 30, 2023 includes a cash deposit of $ 360,000 with Bank of America as required under the Commercial Credit Card Program with a balance equal to the outstanding credit limit on commercial credit cards. Fair Value of Financial Instruments and Credit Risk At September 30, 2023, the Company’s financial instruments included cash equivalents, accounts payable, accrued expenses and notes payable. The carrying amount of cash equivalents, accounts payable and accrued expenses approximated fair value, given their short-term nature. The carrying value of the notes payable approximates fair value as the interest rate is reflective of current market rates on debt with similar terms and conditions. Cash equivalents subject the Company to concentrations of credit risk. However, the Company invests its cash in accordance with a policy objective that seeks to ensure both liquidity and safety of principal. The policy limits investments to instruments issued by the U.S. government, certain SEC registered money market funds that invest only in U.S. government obligations and various other low-risk liquid investment options, and places restrictions on portfolio maturity terms. Accounts receivable, trade subjects the Company to concentrations of credit risk as all of the Company's revenue is from sales of a single product, YCANTH t o one pharmaceutical wholesale/distributor. Accounts Receivable, Trade Trade receivables, net of allowance for doubtful accounts related to YCANTH sales, which are recorded in net accounts receivable on the balance sheet, were approximately $ 3.9 million as of September 30, 2023. As of September 30, 2023, the Company had no allowance for doubtful accounts. An allowance for doubtful accounts is determined based on the Company's assessment of the creditworthiness and financial condition of its customers, aging of receivables, as well as the general economic environment. Any allowance would reduce the net receivables to the amount that is expected to be collected. Current payment terms for YCANTH are approximately one-third upon 30 days, one-third upon 60 days and one-third upon 90 days from the shipment date. Inventory The Company values inventory at the lower of cost or net realizable value. Inventory cost is determined using the specific identification method. The Company regularly reviews its inventory quantities and, when appropriate, records a provision for obsolete and excess inventory to derive the new cost basis, which takes into account the Company’s sales forecast and corresponding expiry dates. The Company has not recognized a provision for obsolete and excess inventory as of September 30, 2023. On July 21, 2023, the Company received FDA approval for YCANTH for the treatment of molluscum contagiosum and began capitalizing inventory purchases of saleable product from certain suppliers. Prior to FDA approval, all product purchased from such suppliers was included as a component of research and development expense, as the Company was unable to assert that the inventory had future economic benefit until YCANTH received FDA approval. Pursuant to the supply agreement (Note 10), the Company purchased and included in research and development expenses approximately $ 4.5 million of raw cantharidin and processed active pharmaceutical ingredient ("API"). The raw cantharidin and processed API is sufficient to produce approximately 14 million finished drug product applicators to be used for commercially saleable product and other VP-102 product candidates. In addition, the Company purchased other components and services related to YCANTH for commercially saleable product and included approximately $ 1.2 million in research and development expenses prior to FDA approval. As a result, cost of product revenue related to YCANTH will initially reflect a lower average per unit cost of materials over approximately the next nine months as previously expensed inventory is utilized for commercial production and sold to customers. If the Company were to have included those costs previously expensed as a component of cost of product revenue, the Company’s cost of product revenue for the three and nine months ended September 30, 2023 would have been $ 0.3 million. Debt Issuance Costs Debt issuance costs incurred in connection with the Loan Facility (Note 7) are amortized to interest expense over the term of the financing arrangement using the effective-interest method. Debt issuance costs, net of related amortization are deducted from the carrying value of the related debt. Product Revenue, Net The Company recognizes revenue from sales of a single product, YCANTH (the “Product”) in accordance with ASC Topic 606 – Revenue from Contracts with Customers . YCANTH became available for commercial sale and shipment to patients with a prescription in the United States in the three months ended September 30, 2023. The Company sells the Product to one customer, a pharmaceutical wholesaler/distributor (the “Customer”) who in turn sells the Product directly to clinics, hospitals, and federal healthcare programs. Revenue is recognized as the Product is physically delivered to the Customer. Gross product sales are reduced by corresponding gross-to-net (“GTN”) estimates using the expected value method, resulting in the Company’s reported “Product revenue, net” in the accompanying consolidated statements of operations. Product revenue, net reflects the amount the Company ultimately expects to realize in net cash proceeds, taking into account the current period gross sales and related cash receipts and the subsequent cash disbursements on these sales that the Company estimates for the various GTN categories discussed below. The GTN estimates are based upon information received from external sources, such as written or oral information obtained from our customers with respect to their period-end inventory levels and sales to end-users during the period, in combination with management’s informed judgments. Due to the inherent uncertainty of these estimates, the actual amount of product returns, government chargebacks, prompt pay discounts, commercial rebates, Medicaid rebates, co-pay assistance and distribution, data, and group purchasing organizations ("GPO") administrative fees may be materially above or below the amount estimated. Variance between actual amounts and estimated amounts may result in prospective adjustments to reported net product revenue. Each of the GTN estimate categories are discussed below: Product Returns Allowances : The Customer is contractually permitted to return purchased Product in certain circumstances. The Company estimates expected returns based on the Company’s review of similar products in the industry. As historical data for returns of the Product becomes available over time, the Company will utilize historical return rates of the Product in making its estimates. Returned Product is typically destroyed, since substantially all returns are due to expiry and cannot be resold. Government Chargebacks : The Product is subject to pricing limits under certain federal government programs, including Medicare and the 340B drug pricing program. Qualifying entities (the “End-Users”) purchase the Product from the Customer at their applicable qualifying discounted price. The chargeback amount the Company incurs represents the difference between the Company’s contractual sales price to the Customer and the end-user’s applicable discounted purchase price under the government program. Medicaid Rebates: The Product is subject to state government-managed Medicaid programs, whereby rebates are issued to participating state governments. These rebates arise when a patient treated with the Product is covered under Medicaid, resulting in a discounted price for the Product under the applicable Medicaid program. The Medicaid rebate accrual calculations require the Company to project the magnitude of its sales, by state, that will be subject to these rebates. Patient Assistance: The Company offers a voluntary co-pay patient assistance program intended to provide financial assistance to eligible patients with a prescription drug co-payment required by payors and coupon programs for cash payors. The calculation of the current liability for this assistance is based on an estimate of claims and the cost per claim that the Company expects to receive associated with YCANTH that has been recognized as revenue but remains in the distribution channel inventories at the end of each reporting period. Distribution, Data, and GPO Administrative Fees: Distribution, data, and GPO administrative fees are paid to authorized wholesalers/distributors of the Company’s products for various commercial services including contract administration, inventory management, delivery of end-user sales data, and product returns processing. These fees are based on a contractually-determined percentage of the Company’s applicable sales. Cost of Product Revenue Cost of product revenue includes the cost of inventory sold, which includes direct manufacturing, production and packaging materials for YCANTH sales. Prior to FDA approval in July 2023, the Company expensed approximately $ 0.1 million in costs associated with the manufacturing of YCANTH as a component of research and development expense. Therefore these costs are not included in cost of product revenue. Advertising Expense Advertising expenses, comprised primarily of print and digital assets, social media and internet advertising as well as search engine marketing, are expensed as incurred and are included in selling, gener al, and administrative expenses. For the three and nine months ending September 30, 2023 advertising expenses were approximately $ 1.7 million and $ 2.4 million, respectively. Net Income (Loss) Per Share Basic net income (loss) per share of common stock is computed by dividing net income (loss) by the weighted average number of shares of common stock outstanding during each period including pre-funded warrants to purchase 4,064,814 shares of common stock that were issued in an underwritten offering in February 2023 (Note 8). The pre-funded warrants to purchase common stock are included in the calculation of basic and diluted net income (loss) per share as the exercise price of $ 0.0001 per share is non-substantive and is virtually assured. Diluted net income (loss) per share of common stock includes the effect, if any, from the potential exercise or vesting of securities, such as stock options, restricted stock units and warrants, which would result in the issuance of incremental shares of common stock. However, potential common shares are excluded if their effect is anti-dilutive. For diluted net income (loss) per share in periods where the Company has a net loss, the weighted average number of shares of common stock is the same for basic net loss per share due to the fact that when a net loss exists, dilutive securities are not included in the calculation as the impact is anti-dilutive. For the three months ended September 30, 2022, the Company was in a net income position and calculated the diluted net income per share by dividing the Company’s net income by the dilutive weighted-average number of shares outstanding during the period, determined using the treasury stock method and the average stock price during the period. A reconciliation of the numerators and denominators of the basic and diluted net income (loss) per share calculations are as follows (in thousands, except share and per share data): For the Three Months Ended September 30, For the Nine Months Ended September 30, 2023 2022 2023 2022 Basic net (loss) income per common share calculation: Net (loss) income attributable to common stockholders $ ( 24,802 ) $ 83 $ ( 42,381 ) $ ( 18,555 ) Net (loss) income attributable to common stockholders - basic ( 24,802 ) 83 ( 42,381 ) ( 18,555 ) Weighted average common shares outstanding - basic 46,073,932 40,304,923 45,015,900 31,827,844 Net (loss) income per share - basic $ ( 0.54 ) $ 0.00 $ ( 0.94 ) $ ( 0.58 ) Net (loss) income attributable to common stockholders $ ( 24,802 ) $ 83 $ ( 42,381 ) $ ( 18,555 ) Diluted net (loss) income ( 24,802 ) 83 ( 42,381 ) ( 18,555 ) Stock options — 16,716 — — Weighted average common shares outstanding - diluted 46,073,932 40,321,639 45,015,900 31,827,844 Net (loss) income per share - diluted $ ( 0.54 ) $ 0.00 $ ( 0.94 ) $ ( 0.58 ) The table below provides potential shares outstanding that were not included in the computation of basic and diluted net loss per share of common stock, as the inclusion of these securities would have been anti-dilutive As of September 30, 2023 2022 Shares issuable upon exercise of stock options 5,497,015 3,826,366 Non-vested shares under restricted stock grants 561,500 425,000 Shares issuable upon exercise of warrants pursuant to debt financing 518,551 — Total 6,577,066 4,251,366 Recently Adopted Accounting Pronouncements In June 2022, the FASB issued Accounting Standards Update No. 2022-03, Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions. This standard clarifies that a contractual restriction on the sale of an equity security is not considered part of the unit of account of the equity security and, therefore, is not considered in measuring fair value. This standard becomes effective for the Company on January 1, 2024, and is not expected to have a material impact on the Company’s financial statements and related disclosures. In June 2016, the FASB issued ASU 2016-13, Financial Instruments—Credit Losses, Measurement of Credit Losses on Financial Instruments (Topic 326). The standard amends the impairment model by requiring entities to use a forward-looking approach based on expected losses to estimate credit losses for most financial assets and certain other instruments that are not measured at fair value through net income. For available-for-sale debt se curities, entities will be required to recognize an allowance for credit losses rather than a reduction in carrying value of the asset. Entities will no longer be permitted to consider the length of time that fair value has been less than amortized cost when evaluating when credit losses should be recognized. The Company adopted this guidance on January 1, 2023 and its adoption did not have an impact on the Company's financial statements and related disclosures. |
Property and Equipment
Property and Equipment | 9 Months Ended |
Sep. 30, 2023 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Note 3—Property and Equipment Property and equipment, net consisted of (in thousands): As of As of September 30, December 31, 2023 2022 Machinery and equipment $ 1,387 $ 1,392 Office equipment 326 301 Office furniture and fixtures 303 303 Leasehold improvements 54 54 Construction in process 2,532 2,536 4,602 4,586 Accumulated depreciation ( 1,044 ) ( 699 ) Total property and equipment, net $ 3,558 $ 3,887 The Company has recorded an asset classified as construction in process associated with the construction of a product assembly and packaging line which will be placed in service after commercial launch and additional testing. |
Inventory
Inventory | 9 Months Ended |
Sep. 30, 2023 | |
Inventory Disclosure [Abstract] | |
Inventory | Note 4 - Inventory Upon FDA approval of YCANTH for the treatment of molluscum contagiosum on July 21, 2023, the Company began capitalizing the purchases of saleable inventory of YCANTH from suppliers. Invento ry consisted of the following (in thousands): September 30, December 31, 2023 2022 Raw materials $ 116 $ — Work in process — — Finished goods 163 — Total inventory $ 279 $ — |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 9 Months Ended |
Sep. 30, 2023 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses and Other Current Liabilities | Note 5—Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following (in thousands): As of As of December 31, Gross to net reserves $ 3,126 $ — Clinical trials and drug development 2,127 974 Compensation and related costs 2,038 1,399 Professional fees 1,250 58 Other current liabilities 282 — Commercial-related costs 186 — Machinery and equipment 57 57 Construction in process 36 167 Total accrued expenses and other current liabilities $ 9,102 $ 2,655 |
Leases
Leases | 9 Months Ended |
Sep. 30, 2023 | |
Leases [Abstract] | |
Leases | N ote 6—Leases The Company leases office space in West Chester, Pennsylvania that serves as the Company’s headquarters under an agreement classified as an operating lease. The initial term will expire on September 1, 2027 . Base rent over the initial term is approximately $ 2.4 million, and the Company is also responsible for its share of the landlord’s operating expense. The Company lea ses office space in Scotch Plains, New Jersey under an agreement classified as an operating lease, which commenced on May 1, 2022 and expires on April 30, 2025 . Base rent over the initial term is approximately $ 104,000 . The Company has entered into an automobile fleet lease program for its sales force. As of September 30, 2023 tthe majority of the vehicles had not yet been delivered. The term of the leases is 52 months and the ROU asset recognized for the leases of vehicles delivered as of September 30, 2023 was $ 0.1 million. The components of lease expense are as follows (in thousands): For the Three Months Ended September 30, For the Nine Months Ended September 30, 2023 2022 2023 2022 Finance lease cost: Amortization ROU assets $ 1 $ 1 $ 1 $ 4 Total finance lease costs $ 1 $ 1 $ 1 $ 4 Operating lease: Operating lease costs $ 93 $ 95 $ 278 $ 272 Short-term lease costs — — — 7 Total operating lease expense $ 93 $ 95 $ 278 $ 279 Maturities of the Company’s operating and finance leases, excluding short-term leases are as follows (in thousands): For the Nine Months Ended September 30, 2023 Operating Finance 2023 (remaining 3 months) $ 97 $ 9 2024 390 37 2025 372 32 2026 366 27 2027 246 25 Thereafter — 2 Total lease payments 1,471 132 Less imputed interest ( 166 ) ( 20 ) Lease liability $ 1,305 $ 112 The table below presents the weighted average remaining lease term and discount rates for the Company's leases as of September 30, 2023: For the Nine Months Ended September 30, 2023 Operating Finance Weighted average remaining lease term 3.82 4.25 Weighted average discount rate 6.25 % 7.75 % |
Debt
Debt | 9 Months Ended |
Sep. 30, 2023 | |
Debt Disclosure [Abstract] | |
Debt | Note 7—Debt On July 11, 2022, the Company voluntarily repaid its previous debt facility (the “Mezzanine Loan Agreement”) in full of $ 43.8 million, inclusive of principal amount of debt, the final payment fee, and accrued interest, and satisfied all of the Company’s outstanding debt obligations. The Company did not incur any prepayme nt penalties in connection with the repayment of the debt. The prepayment was made in full using restricted cash of $ 40.0 million, as well as cash on hand of $ 3.8 million for the final payment fee. For the year ended December 31, 2022, the Company recognized a $ 1.4 million loss on debt extinguishment which was made up entirely of non-cash unamortized debt issuance costs. For the three and nine months ended September 30, 2022, the Company recognized interest exp ense related to the terminated facility of $ 0.1 million and $ 2.2 million, respectively of which $ 0.1 million and $ 1.6 million, respectively was interest on the term loan and $ 0.0 million and $ 0.6 million, respectively was non-cash interest expense related to the amortization of deferred deb t issuance costs and accrual of the final payment fee. On July 26, 2023 (the “Closing Date”), the Company entered into a Credit Agreement (the “Credit Agreement”), by and between the Company, as borrower, and OrbiMed Royalty & Credit Opportunities IV, LP, a Delaware limited partnership (the “Initial Lender”), as a lender, and each other lender that may from time to time become a party thereto (each, including the Initial Lender, and together with their affiliates, successors, transferees and assignees, the “Lenders”), and OrbiMed Royalty & Credit Opportunities IV, LP, as administrative agent for the Lenders (in such capacity, the “Administrative Agent”). The Credit Agreement provides for a five-year senior secured credit facility in an aggregate principal amount of up to $ 125.0 million (the “Loan Facility”), of which $ 50.0 million was made available on the Closing Date ("Initial Commitment Amount"), up to $ 25.0 million will be made available on or prior to June 30, 2024, up to $ 30.0 million will be made available on or prior to December 31, 2024, up to $ 10.0 million will be made available on or prior to March 31, 2025, and up to $ 10.0 million will be made available on or prior to June 30, 2025, in each case, subject to the Company's achievement of certain revenue targets. Amounts borrowed under the Loan Facility will mature on July 26, 2028 . On July 26, 2023, the Company closed on the Initial Commitment Amount, resulting in net proceeds to the Company of approximately $ 44.1 million after payment of certain fees and transaction related expenses of $ 5.9 million. During the term of the Loan Facility, interest payable in cash by the Company shall accrue on any outstanding balance due under the Loan Facility at a rate per annum equal to the higher of (x) the SOFR rate (which is the forward-looking term rate for a one-month tenor based on the secured overnight financing rate administered by the CME Group Benchmark Administration Limited) and (y) 4.00 % plus, in either case, 8.00 %. During an event of default, any outstanding amount under the Loan Facility will bear interest at a rate of 4.00 % in excess of the otherwise applicable rate of interest. The Company paid or will pay certain fees with respect to the Loan Facility, including an upfront fee, an unused fee on the undrawn portion of the Loan Facility, an administration fee, a prepayment premium and an exit fee, as well as certain other fees and expenses of the Administrative Agent and the Lenders. On the Closing Date, the Company also issu ed the Initial Lender warrants to purchase up to 518,551 shares of the Company’s common stock, at an exercise price of $ 6.0264 per share, which has as a term of 10 years from the issuance date. The warrants were deemed to be classified as equity per the guidance ASC 815 Derivatives and Hedging . The proceeds from the debt transaction were allocated among the two instruments based on their relative fair values. The relative fair value of the warrants was determined to be $ 2.0 million and the fair value was determined to be $ 2.4 million based on the black-scholes valuation technique and the key assumptions used were as follows: (i) an expected term of 10 years, (ii) an expected volatility of 94.86 %, (iii) a risk free rate of 3.86 % and (iv) no estimated dividend yield. Th e Loan Facility will be classified as non-current debt at issuance as the Company does not currently intend to repay amounts borrowed under the Loan Facility prio r to the maturity date of July 26, 2028 and believes that the probability of any acceleration of the Loan Facility is not probable at September 30, 2023. The Company has incurred debt discount and issuance costs of $ 10.4 million, that are classified as a contra-liability on the condensed balance sheet. The debt discount and issuance costs consists of $ 5.9 million paid in cash during the three months ended September 30, 2023 and the final payment fee of $ 2.5 million, classified as a long-term liability and the fair value of the warrants of $ 2.0 million, classified as equity on the condensed balance sheet. For the three and nine months ended September, 2023, the Company recognized interest expense related to the Credit Agreement of $ 1.6 million, of which $ 1.3 million was interest on the term loan and $ 0.3 million was non-cash interest expense related to the amortization of deferred deb t issuance costs and accrual of the final payment fee. The following table summarizes the composition of debt as reflected on the balance sheet as of September 30, 2023 (in thousands): Gross proceeds $ 50,000 Accrued final payment fee 2,500 Unamortized debt discount and issuance costs ( 10,099 ) Total short-term debt, net $ 42,401 |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2023 | |
Equity [Abstract] | |
Stockholders' Equity | Note 8—Stockholders' Equity Common Stock The Company had authorized 200,000,000 shares of common stock, $ 0.0001 par value per share, as of September 30, 2023 and December 31, 2022. Each share of common stock is entitled to one vote. Common stock owners are entitled to dividends when funds are legally available and declared by the Board. Underwritten Public Offering In February 2023, the Company closed an underwritten offering of 750,000 shares of its common stock and pre-funded warrants to purchase 4,064,814 shares of common stock. The shares of common stock were sold at a price of $ 6.75 per share and the pre-funded warrants were sold at a price of $ 6.7499 per pre-funded warrant, resulting in net proceeds of $ 30.3 million after deducting underwriting discounts and commissions, and offering expense. The pre-funded warrants will not expire and are exercisable in cash or by means of a cashless exercise. Warrants The following table summarizes the Company’s outstanding warrants as of September 30, 2023: As of September 30, 2023 Number of warrants Exercise Price Expiration Date Pre-funded warrants pursuant to common stock issuance 4,064,814 $ 0.0001 No expiration Warrants issued with OrbiMed debt facility 518,551 $ 6.0264 7/25/2033 Stock-Based Compensation Stock-based compensation expense, which includes expense for both employees and non-employees, has been reported in the Company’s condensed statements of operations for the three and nine months ended September 30, 2023 and 2022 as follows (in thousands): For the Three Months Ended September 30, For the Nine Months Ended September 30, 2023 2022 2023 2022 Selling, general and administrative $ 8,438 $ 1,064 $ 10,223 $ 2,709 Research and development 1,225 349 2,078 1,105 Total stock-based compensation $ 9,663 $ 1,413 $ 12,301 $ 3,814 Stock Options The following table summarizes the Company’s stock option activity for the nine months ended September 30, 2023: Weighted average Weighted average remaining contractual Aggregate intrinsic Number of shares exercise price term (in years) value Outstanding as of December 31, 2022 3,932,779 $ 8.99 7.8 $ 3,952,803 Granted 1,578,836 6.66 Exercised ( 8,000 ) 0.90 Forfeited and Expired ( 6,600 ) 5.13 Outstanding as of September 30, 2023 5,497,015 $ 8.34 7.4 $ 455,190 Options vested and exercisable as of 2,898,680 $ 9.12 6.1 $ 245,112 As of September 30, 2023 , the total unrecognized compensation related to unvested stock option awards granted was $ 13.1 million, which the Company expects to recognize over a weighted average period of 2.7 years. Restricted Stock I n November 2019 and August 2020 the Company granted 300,000 and 250,000 restricted stock units ("RSU"), respectively, to its executive officers of which 125,000 were forfeited. 50 % of the remaining RSUs vested upon receipt of regulatory approval of YCANTH (VP-102) for the treatment of molluscum on July 21, 2023 (the “Approval Date”) and 50 % will vest on the one year anniversary of the Approval Date subject to the holders’ continuous service through each applicable date. In March 2023, the Company granted 698,000 RSUs, 50 % of which vested upon the first commercial sale of YCANTH (VP-102) on August 24, 2023 (the “First Sale Date” ) and 50 % will vest on the one year anniversary of the Fi rst Sale Date subject to the holders’ continuous service through each applicable date. Shares of common stock related to the 349,000 of RSUs which vested on the First Sale Date will not be issued until the Company's trading window opens. The following is a summary of activity of the Company's RSUs for the nine months ended September 30, 2023: Weighted Average Grant Date Fair Number of Shares Value Nonvested as of December 31, 2022 425,000 $ 11.68 Granted 698,000 7.58 Forfeited — — Vested ( 561,500 ) 9.13 Nonvested as of September 30, 2023 561,500 $ 9.13 Compensation expense of $ 8.2 million was recognized during the three and nine months ended September 30, 2023 related to the vested RSUs based on the fair market value at the date of grant. As of September 30, 2023, the remaining unrecognized compensation expense related to the restricted stock units was $ 2.1 million, which the Company expects to recognize over a weighted average service period of 0.5 years now that vesting of these awards is probable. |
Related Party Transactions
Related Party Transactions | 9 Months Ended |
Sep. 30, 2023 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Note 9—Related Party Transactions Prior to the completion of the initial public offering of the Company’s common stock in June 2018, the Company was controlled by PBM VP Holdings, LLC (“PBM VP Holdings”), an affiliate of PBM Capital Group, LLC (“PBM”). Paul B. Manning, who is the Chairman and Chief Executive Officer of PBM and the current chairman of the Company’s Board of Directors, and certain entities affiliated with Mr. Manning, continue to be the Company’s largest stockholder on a collective basis. On December 2, 2015, the Company entered into a Services Agreement (the “SA”) with PBM. Pursuant to the terms of the SA, which had an initial term of twelve months (and was automatically renewable for successive monthly periods), PBM rendered advisory and consulting services to the Company. Services provided under the SA included certain business development, operations, technical, contract, accounting and back office support services. In consideration for these services, the Company was obligated to pay PBM a monthly management fee. On October 1, 2019, the SA was amended to reduce the monthly management fee to $ 5,000 as a result of a reduction in services provided by PBM. For the three months ended September 30, 2023 and 2022 , the Company recognized expenses under the SA of $ 15,000 and $ 20,000 respectively, of which $ 9,000 and $ 12,000 , respectively, were included in selling, general and administrative expenses and $ 6,000 and $ 8,000 , respectively, were included in research and development expenses. For each of the nine months ended September 30, 2023 and 2022 , the Company recognized expenses under the SA of $ 45,000 , of which $ 27,000 were included in selling, general and administrative expenses and $ 18,000 were included in research and development. As of September 30, 2023 , the Company had a $ 5,000 outstanding payable due to PBM and its affiliate s. O n September 8, 2022, the Company entered into a clinical service agreement with Clinical Enrollment LLC which is controlled by Bryan Manning, the son of Paul B. Manning, who is the current chairman of the Company's Board of Directors. Paul B. Manning along with certain entities affiliated with Mr. Manning, are the Company's largest stockholder on a collective basis. Pursuant to the clinical service agreement, Clinical Enrollment LLC may provide recruiting support services for the Company's VP-315 clinical trial. No fees were due under the agreement until a minimu m number of patients are enrolled in the clinical trial by the vendor. Compensation of $ 30,000 was recognized during the year ended December 31, 2022 for the development and production fee of media, video, and web to support recruitment services. After meeting the minimum enrollments, compensation includes a $ 15,000 fee per eligible patient enrolled in the trial. Compensation of $ 0.1 million of expenses were incurred for the nine months ended September 30, 2023 , all of which was classified as research and development expenses with no outstanding payables. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 10—Commitments and Contingencies Litigation On June 6, 2022, plaintiff Kranthi Gorlamari (“Gorlamari”) filed a putative class action complaint captioned Gorlamari v. Verrica Pharmaceuticals Inc., et al., in the U.S. District Court for the Eastern District of Pennsylvania against the Company and certain of its current and former officers and directors (“Defendants”). Gorlamari filed an amended complaint on January 12, 2023. The amended complaint alleges that Defendants violated federal securities laws by, among other things, failing to disclose certain manufacturing deficiencies at the facility where our contract manufacturer produced bulk solution for the VP-102 drug device and that such deficiencies posed a risk to the prospects for regulatory approval of VP-102 for the treatment of molluscum. The amended complaint seeks unspecified compensatory damages and other relief on behalf of Gorlamari and all other persons and entities which purchased or otherwise acquired our securities between May 19, 2021 and May 24, 2022. Briefing on Defendants’ motion to dismiss the amended complaint was completed on May 23, 2023. The litigation is still in the early stages, and the Company intends to vigorously defend itself against these allegations. The Company is also involved in ordinary, routine legal proceedings that are not considered by management to be material. In the opinion of Company counsel and management, the ultimate liabilities resulting from such legal proceedings will not materially affect the financial position of the Company or its results of operations or cash flows. Supply Agreement and Purchase Order On July 16, 2018, the Company entered into a supply agreement with a supplier of crude cantharidin material. All executed purchase orders for crude cantharidin in the ordinary course of business are expected to be covered under the terms of the supply agreement. Pursuant to the supply agreement, th e supplier has agreed that it will not supply cantharidin, any beetles or other raw material from which cantharidin is derived to any other customer in North America, subject to specified minimum annual purchase orders and forecasts by the Company. The supply agreement had an initial five-year term, and now renews for successive annual periods absent termination by either party in accordance with the terms of the supply agreement. Each party also has the right to terminate the supply agreement for other customary reasons such as material breach or bankruptcy. Durin g 2022 and 2021, the Company executed a purchase order pursuant to which the Company agreed to purchase $ 0.7 million and $ 0.8 million, respectively of cr ude cantharidin material and made prepayments of $ 0.7 million and $ 0.8 million in each year against the purchase orders. As of September 30, 2023 , the Company has received the shipments for the purchases during 2022 and 2021. The 2022 and 2021 executed purchase orders of crude cantharidin were received in June 2023 and April 2023, respectively. As of December 31, 2022, the balance sheet reflects prepaid expense of $ 1.5 million. The Company agreed to purchase an additional $ 0.7 million of crude cantharidin during the three months ended September 30, 2023, of which $ 0.1 million was classified in prepaid expenses on the condensed balance sheet as of September 30, 2023. |
License And Collaboration Agree
License And Collaboration Agreements | 9 Months Ended |
Sep. 30, 2023 | |
License And Collaboration Agreements [Abstract] | |
License and Collaboration Agreements | Note 11—License and Collaboration Agreements On March 17, 2021, the Company entered into a collaboration and license agreement (the “Torii Agreement”) with Torii, pursuant to which the Company granted Torii an exclusive license to develop and commercialize the Company’s product candidates that contain a topical formulation of cantharidin for the treatment of molluscum contagiosum and common warts in Japan, including VP-102. Additionally, the Company granted Torii a right of first negotiation with respect to additional indications for the licensed products and certain additional products for use in the licensed field, in each case in Japan. Pursu ant to the Torii Agreement, the Company received payments from Torii of $ 0.5 million in December 2020 and $ 11.5 million in April 2021. On July 25, 2022 Torii dosed the first patient in its Phase 3 trial of VP-102 (referred to as TO-208 in Japan) for molluscum contagiosum in Japan, triggering an $ 8.0 million milestone payment. Additionally, the Company is entitled to receive from Torii an additional $ 50 million in aggregate payments from Torii contingent on achievement of specified development, regulatory, and sales milestones, in addition to tiered transfer price payments for supply of product in the percentage range of the mid- 30 ’s to the mid- 40 ’s of net sales. The transfer payments shall be payable, on a product-by-product basis, beginning on the first commercial sale of such product and ending on the latest of (a) expiration of the last-to-expire valid claim contained in certain licensed patents in Japan that cover such product, (b) expiration of regulatory exclusivity for the first indication for such product in Japan, and, (c) (i) with respect to the first product, ten years after first commercial sale of such product, and, (ii) with respect to any other product, the later of (x) ten years after first commercial sale of the first product and (y) five years after first commercial sale of such product. The Torii Agreement expires on a product-by-product basis upon expiration of Torii’s obligation under the agreement to make transfer price payments for such product. Torii has the right to terminate the agreement upon specified prior written notice to us. Additionally, either party may terminate the agreement in the event of an uncured material breach of the agreement by, or insolvency of, the other party. The Company may terminate the agreement in the event that Torii commences a legal action challenging the validity, enforceability or scope of any licensed patents. On March 7, 2022, the Company executed a Clinical Supply Agreement with Torii, whereby the Company will supply product to Torii for use in clinical trials and other development activities. The Company recognized billed and unbilled collaboration revenue of $ 0.1 and $ 0.3 million, respectively for the three months ended September 30, 2023 and 2022 and $ 0.3 and $ 1.0 million, respectively for the nine months ended September 30, 2023 and 2022, respectively related to supplies and development activity pursuant to this agreement. The costs of collaboration revenue consists of expenses incurred by the Company for manufacturing supply to support development and testing services pursuant to the Torii Clinical Supply Agreement. In August 2020, the Company entered into an exclusive license agreement with Lytix Biopharma AS (“Lytix”) for the use of licensed technology to research, develop, manufacture, have manufactured, use, sell, have sold, offer for sale, import, and otherwise commercialize products for use in all malignant and pre-malignant dermatological indications, other than metastatic melanoma and metastatic merkel cell carcinoma (the” Lytix Agreement”). As part of the Lytix Agreement, the Company paid Lytix a one-time up-front fee of $ 0.3 million in 2020. In addition, in May 2022 and February 2021, the Company paid Lytix a one-time $ 1.0 million and $ 2.3 million payment, respectively upon the achievement by Lytix of a regulatory milestone. The $ 1.0 and $ 2.3 million payments were recognized in research and development expense in the statement of operations for the nine months ended September 30, 2022 and for the year ended December 31, 2021, respectively. The Company is also obligated to pay up to $ 111.0 million contingent on achievement of specified development, regulatory, and sales milestones, as well as tiered royalties based on worldwide annual net sales ranging in the low double digits to the mid-teens, subject to certain customary reductions. The Company’s obligation to pay royalties expires on a country-by-country and product-by-product basis on the later of the expiration or abandonment of the last to expire licensed patent covering LTX-315 anywhere in the world and expiration of regulatory exclusivity for LTX-315 in such country. Additionally, all upfront fees and milestone based payments received by the Company from a sublicensee will be treated as net sales and will be subject to the royalty payment obligations under the Lytix Agreement, and all royalties received by the Company from a sublicensee shall be shared with Lytix at a rate that is initially 50 % but decreases based on the stage of development of LTX-315 at the time such sublicense is granted. |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying unaudited interim condensed financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”) as determined by the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) for interim financial information. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, the unaudited interim condensed financial statements reflect all adjustments, which include only normal recurring adjustments necessary for the fair statement of the balances and results for the periods presented. They may not include all of the information and footnotes required by GAAP for complete financial statements. Therefore, these financial statements should be read in conjunction with the Company’s audited financial statements and notes thereto for the year ended December 31, 2022 included in its Form 10-K, filed with the Securities and Exchange Commission (the “SEC”) on March 6, 2023. The results of operations for any interim periods are not necessarily indicative of the results that may be expected for the entire fiscal year or any other interim period. |
Use of Estimates | 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 the reported amounts of expenses during the reporting period. These estimates and assumptions are based on current facts, historical experience as well as other pertinent industry and regulatory authority information 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. Reclassifications Certain prior period amounts have been reclassified to conform with current period presentation. |
Significant Accounting Policies | Collateral Cash Cash and cash equivalents at September 30, 2023 includes a cash deposit of $ 360,000 with Bank of America as required under the Commercial Credit Card Program with a balance equal to the outstanding credit limit on commercial credit cards. |
Fair Value of Financial Instruments and Credit Risk | Fair Value of Financial Instruments and Credit Risk At September 30, 2023, the Company’s financial instruments included cash equivalents, accounts payable, accrued expenses and notes payable. The carrying amount of cash equivalents, accounts payable and accrued expenses approximated fair value, given their short-term nature. The carrying value of the notes payable approximates fair value as the interest rate is reflective of current market rates on debt with similar terms and conditions. Cash equivalents subject the Company to concentrations of credit risk. However, the Company invests its cash in accordance with a policy objective that seeks to ensure both liquidity and safety of principal. The policy limits investments to instruments issued by the U.S. government, certain SEC registered money market funds that invest only in U.S. government obligations and various other low-risk liquid investment options, and places restrictions on portfolio maturity terms. Accounts receivable, trade subjects the Company to concentrations of credit risk as all of the Company's revenue is from sales of a single product, YCANTH t o one pharmaceutical wholesale/distributor. |
Accounts Receivable, Trade | Accounts Receivable, Trade Trade receivables, net of allowance for doubtful accounts related to YCANTH sales, which are recorded in net accounts receivable on the balance sheet, were approximately $ 3.9 million as of September 30, 2023. As of September 30, 2023, the Company had no allowance for doubtful accounts. An allowance for doubtful accounts is determined based on the Company's assessment of the creditworthiness and financial condition of its customers, aging of receivables, as well as the general economic environment. Any allowance would reduce the net receivables to the amount that is expected to be collected. Current payment terms for YCANTH are approximately one-third upon 30 days, one-third upon 60 days and one-third upon 90 days from the shipment date. |
Inventory | Inventory The Company values inventory at the lower of cost or net realizable value. Inventory cost is determined using the specific identification method. The Company regularly reviews its inventory quantities and, when appropriate, records a provision for obsolete and excess inventory to derive the new cost basis, which takes into account the Company’s sales forecast and corresponding expiry dates. The Company has not recognized a provision for obsolete and excess inventory as of September 30, 2023. On July 21, 2023, the Company received FDA approval for YCANTH for the treatment of molluscum contagiosum and began capitalizing inventory purchases of saleable product from certain suppliers. Prior to FDA approval, all product purchased from such suppliers was included as a component of research and development expense, as the Company was unable to assert that the inventory had future economic benefit until YCANTH received FDA approval. Pursuant to the supply agreement (Note 10), the Company purchased and included in research and development expenses approximately $ 4.5 million of raw cantharidin and processed active pharmaceutical ingredient ("API"). The raw cantharidin and processed API is sufficient to produce approximately 14 million finished drug product applicators to be used for commercially saleable product and other VP-102 product candidates. In addition, the Company purchased other components and services related to YCANTH for commercially saleable product and included approximately $ 1.2 million in research and development expenses prior to FDA approval. As a result, cost of product revenue related to YCANTH will initially reflect a lower average per unit cost of materials over approximately the next nine months as previously expensed inventory is utilized for commercial production and sold to customers. If the Company were to have included those costs previously expensed as a component of cost of product revenue, the Company’s cost of product revenue for the three and nine months ended September 30, 2023 would have been $ 0.3 million. |
Debt Issuance Costs | Debt Issuance Costs Debt issuance costs incurred in connection with the Loan Facility (Note 7) are amortized to interest expense over the term of the financing arrangement using the effective-interest method. Debt issuance costs, net of related amortization are deducted from the carrying value of the related debt. |
Product Revenue, Net | Product Revenue, Net The Company recognizes revenue from sales of a single product, YCANTH (the “Product”) in accordance with ASC Topic 606 – Revenue from Contracts with Customers . YCANTH became available for commercial sale and shipment to patients with a prescription in the United States in the three months ended September 30, 2023. The Company sells the Product to one customer, a pharmaceutical wholesaler/distributor (the “Customer”) who in turn sells the Product directly to clinics, hospitals, and federal healthcare programs. Revenue is recognized as the Product is physically delivered to the Customer. Gross product sales are reduced by corresponding gross-to-net (“GTN”) estimates using the expected value method, resulting in the Company’s reported “Product revenue, net” in the accompanying consolidated statements of operations. Product revenue, net reflects the amount the Company ultimately expects to realize in net cash proceeds, taking into account the current period gross sales and related cash receipts and the subsequent cash disbursements on these sales that the Company estimates for the various GTN categories discussed below. The GTN estimates are based upon information received from external sources, such as written or oral information obtained from our customers with respect to their period-end inventory levels and sales to end-users during the period, in combination with management’s informed judgments. Due to the inherent uncertainty of these estimates, the actual amount of product returns, government chargebacks, prompt pay discounts, commercial rebates, Medicaid rebates, co-pay assistance and distribution, data, and group purchasing organizations ("GPO") administrative fees may be materially above or below the amount estimated. Variance between actual amounts and estimated amounts may result in prospective adjustments to reported net product revenue. Each of the GTN estimate categories are discussed below: Product Returns Allowances : The Customer is contractually permitted to return purchased Product in certain circumstances. The Company estimates expected returns based on the Company’s review of similar products in the industry. As historical data for returns of the Product becomes available over time, the Company will utilize historical return rates of the Product in making its estimates. Returned Product is typically destroyed, since substantially all returns are due to expiry and cannot be resold. Government Chargebacks : The Product is subject to pricing limits under certain federal government programs, including Medicare and the 340B drug pricing program. Qualifying entities (the “End-Users”) purchase the Product from the Customer at their applicable qualifying discounted price. The chargeback amount the Company incurs represents the difference between the Company’s contractual sales price to the Customer and the end-user’s applicable discounted purchase price under the government program. Medicaid Rebates: The Product is subject to state government-managed Medicaid programs, whereby rebates are issued to participating state governments. These rebates arise when a patient treated with the Product is covered under Medicaid, resulting in a discounted price for the Product under the applicable Medicaid program. The Medicaid rebate accrual calculations require the Company to project the magnitude of its sales, by state, that will be subject to these rebates. Patient Assistance: The Company offers a voluntary co-pay patient assistance program intended to provide financial assistance to eligible patients with a prescription drug co-payment required by payors and coupon programs for cash payors. The calculation of the current liability for this assistance is based on an estimate of claims and the cost per claim that the Company expects to receive associated with YCANTH that has been recognized as revenue but remains in the distribution channel inventories at the end of each reporting period. Distribution, Data, and GPO Administrative Fees: Distribution, data, and GPO administrative fees are paid to authorized wholesalers/distributors of the Company’s products for various commercial services including contract administration, inventory management, delivery of end-user sales data, and product returns processing. These fees are based on a contractually-determined percentage of the Company’s applicable sales. |
Cost of Product Revenue | Cost of Product Revenue Cost of product revenue includes the cost of inventory sold, which includes direct manufacturing, production and packaging materials for YCANTH sales. Prior to FDA approval in July 2023, the Company expensed approximately $ 0.1 million in costs associated with the manufacturing of YCANTH as a component of research and development expense. Therefore these costs are not included in cost of product revenue. |
Advertising Expense | Advertising Expense Advertising expenses, comprised primarily of print and digital assets, social media and internet advertising as well as search engine marketing, are expensed as incurred and are included in selling, gener al, and administrative expenses. For the three and nine months ending September 30, 2023 advertising expenses were approximately $ 1.7 million and $ 2.4 million, respectively. |
Net Income (Loss) Per Share | Net Income (Loss) Per Share Basic net income (loss) per share of common stock is computed by dividing net income (loss) by the weighted average number of shares of common stock outstanding during each period including pre-funded warrants to purchase 4,064,814 shares of common stock that were issued in an underwritten offering in February 2023 (Note 8). The pre-funded warrants to purchase common stock are included in the calculation of basic and diluted net income (loss) per share as the exercise price of $ 0.0001 per share is non-substantive and is virtually assured. Diluted net income (loss) per share of common stock includes the effect, if any, from the potential exercise or vesting of securities, such as stock options, restricted stock units and warrants, which would result in the issuance of incremental shares of common stock. However, potential common shares are excluded if their effect is anti-dilutive. For diluted net income (loss) per share in periods where the Company has a net loss, the weighted average number of shares of common stock is the same for basic net loss per share due to the fact that when a net loss exists, dilutive securities are not included in the calculation as the impact is anti-dilutive. For the three months ended September 30, 2022, the Company was in a net income position and calculated the diluted net income per share by dividing the Company’s net income by the dilutive weighted-average number of shares outstanding during the period, determined using the treasury stock method and the average stock price during the period. A reconciliation of the numerators and denominators of the basic and diluted net income (loss) per share calculations are as follows (in thousands, except share and per share data): For the Three Months Ended September 30, For the Nine Months Ended September 30, 2023 2022 2023 2022 Basic net (loss) income per common share calculation: Net (loss) income attributable to common stockholders $ ( 24,802 ) $ 83 $ ( 42,381 ) $ ( 18,555 ) Net (loss) income attributable to common stockholders - basic ( 24,802 ) 83 ( 42,381 ) ( 18,555 ) Weighted average common shares outstanding - basic 46,073,932 40,304,923 45,015,900 31,827,844 Net (loss) income per share - basic $ ( 0.54 ) $ 0.00 $ ( 0.94 ) $ ( 0.58 ) Net (loss) income attributable to common stockholders $ ( 24,802 ) $ 83 $ ( 42,381 ) $ ( 18,555 ) Diluted net (loss) income ( 24,802 ) 83 ( 42,381 ) ( 18,555 ) Stock options — 16,716 — — Weighted average common shares outstanding - diluted 46,073,932 40,321,639 45,015,900 31,827,844 Net (loss) income per share - diluted $ ( 0.54 ) $ 0.00 $ ( 0.94 ) $ ( 0.58 ) The table below provides potential shares outstanding that were not included in the computation of basic and diluted net loss per share of common stock, as the inclusion of these securities would have been anti-dilutive As of September 30, 2023 2022 Shares issuable upon exercise of stock options 5,497,015 3,826,366 Non-vested shares under restricted stock grants 561,500 425,000 Shares issuable upon exercise of warrants pursuant to debt financing 518,551 — Total 6,577,066 4,251,366 |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements In June 2022, the FASB issued Accounting Standards Update No. 2022-03, Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions. This standard clarifies that a contractual restriction on the sale of an equity security is not considered part of the unit of account of the equity security and, therefore, is not considered in measuring fair value. This standard becomes effective for the Company on January 1, 2024, and is not expected to have a material impact on the Company’s financial statements and related disclosures. In June 2016, the FASB issued ASU 2016-13, Financial Instruments—Credit Losses, Measurement of Credit Losses on Financial Instruments (Topic 326). The standard amends the impairment model by requiring entities to use a forward-looking approach based on expected losses to estimate credit losses for most financial assets and certain other instruments that are not measured at fair value through net income. For available-for-sale debt se curities, entities will be required to recognize an allowance for credit losses rather than a reduction in carrying value of the asset. Entities will no longer be permitted to consider the length of time that fair value has been less than amortized cost when evaluating when credit losses should be recognized. The Company adopted this guidance on January 1, 2023 and its adoption did not have an impact on the Company's financial statements and related disclosures. |
Significant Accounting Polici_3
Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Summary of Reconciliation of Numerators and Denominators of Basic and Diluted Net Income Per Share | A reconciliation of the numerators and denominators of the basic and diluted net income (loss) per share calculations are as follows (in thousands, except share and per share data): For the Three Months Ended September 30, For the Nine Months Ended September 30, 2023 2022 2023 2022 Basic net (loss) income per common share calculation: Net (loss) income attributable to common stockholders $ ( 24,802 ) $ 83 $ ( 42,381 ) $ ( 18,555 ) Net (loss) income attributable to common stockholders - basic ( 24,802 ) 83 ( 42,381 ) ( 18,555 ) Weighted average common shares outstanding - basic 46,073,932 40,304,923 45,015,900 31,827,844 Net (loss) income per share - basic $ ( 0.54 ) $ 0.00 $ ( 0.94 ) $ ( 0.58 ) Net (loss) income attributable to common stockholders $ ( 24,802 ) $ 83 $ ( 42,381 ) $ ( 18,555 ) Diluted net (loss) income ( 24,802 ) 83 ( 42,381 ) ( 18,555 ) Stock options — 16,716 — — Weighted average common shares outstanding - diluted 46,073,932 40,321,639 45,015,900 31,827,844 Net (loss) income per share - diluted $ ( 0.54 ) $ 0.00 $ ( 0.94 ) $ ( 0.58 ) |
Schedule of Potential Shares Outstanding not Included in Computation of Diluted Net Loss Per Share of Common Stock | The table below provides potential shares outstanding that were not included in the computation of basic and diluted net loss per share of common stock, as the inclusion of these securities would have been anti-dilutive As of September 30, 2023 2022 Shares issuable upon exercise of stock options 5,497,015 3,826,366 Non-vested shares under restricted stock grants 561,500 425,000 Shares issuable upon exercise of warrants pursuant to debt financing 518,551 — Total 6,577,066 4,251,366 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment, Net | Property and equipment, net consisted of (in thousands): As of As of September 30, December 31, 2023 2022 Machinery and equipment $ 1,387 $ 1,392 Office equipment 326 301 Office furniture and fixtures 303 303 Leasehold improvements 54 54 Construction in process 2,532 2,536 4,602 4,586 Accumulated depreciation ( 1,044 ) ( 699 ) Total property and equipment, net $ 3,558 $ 3,887 |
Inventory (Tables)
Inventory (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Inventory Disclosure [Abstract] | |
Schedule Of Inventory | Invento ry consisted of the following (in thousands): September 30, December 31, 2023 2022 Raw materials $ 116 $ — Work in process — — Finished goods 163 — Total inventory $ 279 $ — |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities consisted of the following (in thousands): As of As of December 31, Gross to net reserves $ 3,126 $ — Clinical trials and drug development 2,127 974 Compensation and related costs 2,038 1,399 Professional fees 1,250 58 Other current liabilities 282 — Commercial-related costs 186 — Machinery and equipment 57 57 Construction in process 36 167 Total accrued expenses and other current liabilities $ 9,102 $ 2,655 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Leases [Abstract] | |
Summary of Components of Lease Expense | The components of lease expense are as follows (in thousands): For the Three Months Ended September 30, For the Nine Months Ended September 30, 2023 2022 2023 2022 Finance lease cost: Amortization ROU assets $ 1 $ 1 $ 1 $ 4 Total finance lease costs $ 1 $ 1 $ 1 $ 4 Operating lease: Operating lease costs $ 93 $ 95 $ 278 $ 272 Short-term lease costs — — — 7 Total operating lease expense $ 93 $ 95 $ 278 $ 279 |
Schedule of Maturities of Operating and Finance Leases | Maturities of the Company’s operating and finance leases, excluding short-term leases are as follows (in thousands): For the Nine Months Ended September 30, 2023 Operating Finance 2023 (remaining 3 months) $ 97 $ 9 2024 390 37 2025 372 32 2026 366 27 2027 246 25 Thereafter — 2 Total lease payments 1,471 132 Less imputed interest ( 166 ) ( 20 ) Lease liability $ 1,305 $ 112 |
Schedule of Weighted Average Remaining Term and Discount Rate | The table below presents the weighted average remaining lease term and discount rates for the Company's leases as of September 30, 2023: For the Nine Months Ended September 30, 2023 Operating Finance Weighted average remaining lease term 3.82 4.25 Weighted average discount rate 6.25 % 7.75 % |
Debt (Tables)
Debt (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Debt Disclosure [Abstract] | |
Summary of Composition of Debt | The following table summarizes the composition of debt as reflected on the balance sheet as of September 30, 2023 (in thousands): Gross proceeds $ 50,000 Accrued final payment fee 2,500 Unamortized debt discount and issuance costs ( 10,099 ) Total short-term debt, net $ 42,401 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Summary of Company's Outstanding Warrants | The following table summarizes the Company’s outstanding warrants as of September 30, 2023: As of September 30, 2023 Number of warrants Exercise Price Expiration Date Pre-funded warrants pursuant to common stock issuance 4,064,814 $ 0.0001 No expiration Warrants issued with OrbiMed debt facility 518,551 $ 6.0264 7/25/2033 |
Schedule of Stock Based Compensation Expense | Stock-based compensation expense, which includes expense for both employees and non-employees, has been reported in the Company’s condensed statements of operations for the three and nine months ended September 30, 2023 and 2022 as follows (in thousands): For the Three Months Ended September 30, For the Nine Months Ended September 30, 2023 2022 2023 2022 Selling, general and administrative $ 8,438 $ 1,064 $ 10,223 $ 2,709 Research and development 1,225 349 2,078 1,105 Total stock-based compensation $ 9,663 $ 1,413 $ 12,301 $ 3,814 |
Summary of Stock Option Activity | The following table summarizes the Company’s stock option activity for the nine months ended September 30, 2023: Weighted average Weighted average remaining contractual Aggregate intrinsic Number of shares exercise price term (in years) value Outstanding as of December 31, 2022 3,932,779 $ 8.99 7.8 $ 3,952,803 Granted 1,578,836 6.66 Exercised ( 8,000 ) 0.90 Forfeited and Expired ( 6,600 ) 5.13 Outstanding as of September 30, 2023 5,497,015 $ 8.34 7.4 $ 455,190 Options vested and exercisable as of 2,898,680 $ 9.12 6.1 $ 245,112 |
Summary of Non-vested RSUs Activities | The following is a summary of activity of the Company's RSUs for the nine months ended September 30, 2023: Weighted Average Grant Date Fair Number of Shares Value Nonvested as of December 31, 2022 425,000 $ 11.68 Granted 698,000 7.58 Forfeited — — Vested ( 561,500 ) 9.13 Nonvested as of September 30, 2023 561,500 $ 9.13 |
Nature of Business - Additional
Nature of Business - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 9 Months Ended | |||
Jul. 26, 2023 | Feb. 28, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Description Of Business [Line Items] | |||||
Number of common shares sold | 750,000 | ||||
Shares Issued, Price Per Share | $ 6.75 | ||||
Underwriting discounts,commissions and offering expenses | $ 2,200 | ||||
Cash and cash equivalents | $ 84,308 | $ 34,273 | |||
Net proceeds from issuance | 30,301 | $ 26,901 | |||
Accumulated deficit | $ (205,834) | $ (163,453) | |||
Loan Facility [Member] | |||||
Description Of Business [Line Items] | |||||
Credit facility, maximum borrowing capacity | $ 125,000 | ||||
Loans, maturity date | Jul. 26, 2028 | ||||
Term A Loan [Member] | |||||
Description Of Business [Line Items] | |||||
Net proceeds from issuance | $ 44,100 | ||||
Line of credit | 50,000 | ||||
Credit facility, maximum borrowing capacity | $ 125,000 | ||||
Loans, maturity date | Jul. 26, 2028 | ||||
Available on or prior to June 30, 2024 | |||||
Description Of Business [Line Items] | |||||
Line of Credit Facility, Remaining Borrowing Capacity | $ 25,000 | ||||
Available on or prior to June 30, 2024 | Loan Facility [Member] | |||||
Description Of Business [Line Items] | |||||
Line of Credit Facility, Remaining Borrowing Capacity | 25,000 | ||||
Available on or prior to December 31, 2024 | |||||
Description Of Business [Line Items] | |||||
Line of Credit Facility, Remaining Borrowing Capacity | 30,000 | ||||
Available on or prior to December 31, 2024 | Loan Facility [Member] | |||||
Description Of Business [Line Items] | |||||
Line of Credit Facility, Remaining Borrowing Capacity | 30,000 | ||||
Available on or prior to March 31, 2025 | |||||
Description Of Business [Line Items] | |||||
Line of Credit Facility, Remaining Borrowing Capacity | 10,000 | ||||
Available on or prior to March 31, 2025 | Loan Facility [Member] | |||||
Description Of Business [Line Items] | |||||
Line of Credit Facility, Remaining Borrowing Capacity | 10,000 | ||||
Available on or prior to June 30, 2025 | |||||
Description Of Business [Line Items] | |||||
Line of Credit Facility, Remaining Borrowing Capacity | 10,000 | ||||
Available on or prior to June 30, 2025 | Loan Facility [Member] | |||||
Description Of Business [Line Items] | |||||
Line of Credit Facility, Remaining Borrowing Capacity | $ 10,000 | ||||
Pre Funded Warrant [Member] | |||||
Description Of Business [Line Items] | |||||
Warrant issued to purchase company's common stock | 4,064,814 | 4,064,814 | |||
Warrant price (per share) | $ 6.7499 | $ 0.0001 | |||
Net proceeds from issuance | $ 30,300 |
Significant Accounting Polici_4
Significant Accounting Policies - Additional information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | |||||
Jul. 21, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Feb. 28, 2023 | Dec. 31, 2022 | |
Bank cash deposits | $ 360,000 | $ 360,000 | |||||
Accounts receivable | 3,946 | 3,946 | $ 0 | ||||
Allowance for doubtful accounts | 0 | $ 0 | |||||
Basic exercise price | $ 0.0001 | ||||||
Diluted exercise price | $ 0.0001 | ||||||
Advertising expense | 1,700 | $ 2,400 | |||||
Research and development expense | $ 4,500 | 6,510 | $ 2,780 | 14,975 | $ 9,170 | ||
Finished goods | 163 | 163 | $ 0 | ||||
Cost of product revenue | $ 300 | $ 300 | |||||
YCANTH [Member] | |||||||
Research and development expense | 1,200 | ||||||
Finished goods | 14,000 | ||||||
FDA | |||||||
Research and development expense | $ 100 | ||||||
Pre Funded Warrant [Member] | |||||||
Warrant issued to purchase company's common stock | 4,064,814 | 4,064,814 | 4,064,814 |
Significant Accounting Polici_5
Significant Accounting Policies - Summary of Reconciliation of Numerators and Denominators of Basic and Diluted Net Income Per Share (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Basic net (loss) income per common share calculation: | ||||||||
Net (loss) income | $ (24,802) | $ (10,990) | $ (6,589) | $ 83 | $ (10,168) | $ (8,470) | $ (42,381) | $ (18,555) |
Net (loss) income attributable to common stockholders - basic | $ (24,802) | $ 83 | $ (42,381) | $ (18,555) | ||||
Weighted average common shares outstanding - basic | 46,073,932 | 40,304,923 | 45,015,900 | 31,827,844 | ||||
Net (loss) income per share - basic | $ (0.54) | $ 0 | $ (0.94) | $ (0.58) | ||||
Net (loss) income | $ (24,802) | $ (10,990) | $ (6,589) | $ 83 | $ (10,168) | $ (8,470) | $ (42,381) | $ (18,555) |
Diluted net (loss) income | $ (24,802) | $ 83 | $ (42,381) | $ (18,555) | ||||
Stock options | 0 | 16,716 | 0 | 0 | ||||
Weighted average common shares outstanding - diluted | 46,073,932 | 40,321,639 | 45,015,900 | 31,827,844 | ||||
Net (loss) income per share - diluted | $ (0.54) | $ 0 | $ (0.94) | $ (0.58) |
Significant Accounting Polici_6
Significant Accounting Policies - Schedule of Potential Shares Outstanding not Included in Computation of Diluted Net Loss Per Share of Common Stock (Detail) - shares | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Securities that could potentially dilute basic earnings per share | 6,577,066 | 4,251,366 |
Shares issuable upon exercise of stock options [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Securities that could potentially dilute basic earnings per share | 5,497,015 | 3,826,366 |
Non-vested shares under restricted stock grants [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Securities that could potentially dilute basic earnings per share | 561,500 | 425,000 |
Shares issuable upon exercise of warrants pursuant to debt financing [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Securities that could potentially dilute basic earnings per share | 518,551 | 0 |
Property and Equipment - Schedu
Property and Equipment - Schedule of Property and Equipment, Net (Detail) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 4,602 | $ 4,586 |
Accumulated depreciation | (1,044) | (699) |
Total property and equipment, net | 3,558 | 3,887 |
Machinery and Equipment [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 1,387 | 1,392 |
Office Equipment [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 326 | 301 |
Office Furniture and Fixtures [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 303 | 303 |
Leasehold Improvements [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 54 | 54 |
Construction in Progress [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 2,532 | $ 2,536 |
Inventory - Schedule Of Invento
Inventory - Schedule Of Inventory (Detail) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 116 | $ 0 |
Work in process | 0 | 0 |
Finished goods | 163 | 0 |
Total inventory | $ 279 | $ 0 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities - Schedule of Accrued Expenses and Other Current Liabilities (Detail) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Accrued Liabilities, Current [Abstract] | ||
Gross to net reserves | $ 3,126 | $ 0 |
Clinical trials and drug development | 2,127 | 974 |
Compensation and related costs | 2,038 | 1,399 |
Professional fees | 1,250 | 58 |
Other current liabilities | 282 | 0 |
Commercial-related costs | 186 | 0 |
Machinery and equipment | 57 | 57 |
Construction in process | 36 | 167 |
Total accrued expenses and other current liabilities | $ 9,102 | $ 2,655 |
Leases - Additional Information
Leases - Additional Information (Detail) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Dec. 31, 2022 | |
Lessee Lease Description [Line Items] | ||
Lease expiration date | Sep. 01, 2027 | |
ROU asset recognized for the leases | $ 1,339 | $ 1,443 |
NEW JERSEY | ||
Lessee Lease Description [Line Items] | ||
Lease agreement commencement date | May 01, 2022 | |
Lease expiration date | Apr. 30, 2025 | |
Operating lease, base rent | $ 104,000 | |
Automobile Fleet Lease Program | ||
Lessee Lease Description [Line Items] | ||
Term of lease | 52 months | |
ROU asset recognized for the leases | $ 100 | |
Landlord's Operating Expense [Member] | ||
Lessee Lease Description [Line Items] | ||
Operating lease, base rent | $ 2,400 |
Leases - Summary of Components
Leases - Summary of Components of Lease Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Leases [Abstract] | ||||
Amortization ROU assets | $ 1 | $ 1 | $ 1 | $ 4 |
Total finance lease costs | 1 | 1 | 1 | 4 |
Operating lease costs | 93 | 95 | 278 | 272 |
Short-term lease costs | 0 | 0 | 0 | 7 |
Total operating lease expense | $ 93 | $ 95 | $ 278 | $ 279 |
Leases - Schedule of Maturities
Leases - Schedule of Maturities of Operating and Finance Leases (Detail) $ in Thousands | Sep. 30, 2023 USD ($) |
Leases [Abstract] | |
Operating Lease, Remainder of Fiscal Year | $ 97 |
Operating Lease, Year one | 390 |
Operating Lease, Year Two | 372 |
Operating Lease, Year Three | 366 |
Operating Lease, Year Four | 246 |
Operating Lease, After Year Four | 0 |
Operating Lease, Total lease payments | 1,471 |
Less Operating Lease, imputed interest | (166) |
Operating Lease, Lease liability | 1,305 |
Finance Lease, Remainder of Fiscal Year | 9 |
Finance Lease, Year one | 37 |
Finance Lease, Year Two | 32 |
Finance Lease, Year Three | 27 |
Finance Lease, Year Four | 25 |
Finance Lease, After Year Four | 2 |
Finance Lease, Total lease payments | 132 |
Less Finance Lease imputed interest | (20) |
Finance Lease, Lease liability | $ 112 |
Leases - Schedule of Weighted A
Leases - Schedule of Weighted Average Remaining Term and Discount Rate (Detail) | Sep. 30, 2023 |
Leases [Abstract] | |
Operating Lease, Weighted average remaining lease term | 3 years 9 months 25 days |
Operating Lease, Weighted-average discount rate | 6.25% |
Finance Lease, Weighted average remaining lease term | 4 years 3 months |
Finance Lease, Weighted-average discount rate | 7.75% |
Debt - Additional Information (
Debt - Additional Information (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||
Jul. 26, 2023 | Jul. 11, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Debt Instrument [Line Items] | |||||||
Debt instrument, prepayment fee | $ 43,800,000 | ||||||
Cash, cash equivalents and marketable securities and restricted cash | 40,000,000 | ||||||
Final payment fee | $ 3,800,000 | ||||||
Loss on extinguishment of debt | $ 0 | $ (1,437,000) | $ 0 | $ (1,437,000) | $ 1,400,000 | ||
Fair value of the warrants | $ 2,400,000 | ||||||
Common Stock [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Warrant issued to purchase company's common stock | 518,551 | ||||||
Warrant price (per share) | $ 6.0264 | ||||||
Warrant term | 10 years | ||||||
Warrant [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Fair value of the warrants | $ 2,000,000 | ||||||
Expected Term | 10 years | ||||||
Expected volatility | 94.86% | ||||||
Risk free rate | 3.86% | ||||||
Estimated dividend yield | 0% | ||||||
Loan Facility [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Credit facility, maximum borrowing capacity | $ 125,000,000 | ||||||
Initial Commitment Amount | $ 50,000,000 | ||||||
Loans, maturity date | Jul. 26, 2028 | ||||||
Net proceeds after payment of certain fees and transaction related expenses | $ 44,100,000 | ||||||
Transaction related expenses | $ 5,900,000 | ||||||
SOFR | |||||||
Debt Instrument [Line Items] | |||||||
Interest rate (as a percent) | 4% | ||||||
Interest rate (as a percent) | 4% | ||||||
Loans, interest rate | 8% | ||||||
Available on or prior to June 30, 2024 | |||||||
Debt Instrument [Line Items] | |||||||
Remaining Commitment Amount | $ 25,000,000 | ||||||
Available on or prior to June 30, 2024 | Loan Facility [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Remaining Commitment Amount | 25,000,000 | ||||||
Available on or prior to December 31, 2024 | |||||||
Debt Instrument [Line Items] | |||||||
Remaining Commitment Amount | 30,000,000 | ||||||
Available on or prior to December 31, 2024 | Loan Facility [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Remaining Commitment Amount | 30,000,000 | ||||||
Available on or prior to March 31, 2025 | |||||||
Debt Instrument [Line Items] | |||||||
Remaining Commitment Amount | 10,000,000 | ||||||
Available on or prior to March 31, 2025 | Loan Facility [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Remaining Commitment Amount | 10,000,000 | ||||||
Available on or prior to June 30, 2025 | |||||||
Debt Instrument [Line Items] | |||||||
Remaining Commitment Amount | 10,000,000 | ||||||
Available on or prior to June 30, 2025 | Loan Facility [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Remaining Commitment Amount | 10,000,000 | ||||||
Term A Loan [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Credit facility, maximum borrowing capacity | $ 125,000,000 | ||||||
Loans, maturity date | Jul. 26, 2028 | ||||||
Senior Loan Agreement [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Final payment fee | $ 2,000,000 | ||||||
Debt discount and issuance costs | $ 10,400,000 | 5,900 | 5,900 | ||||
Interest expense | 1,600,000 | 100,000 | 1,600,000 | 2,200,000 | |||
Interest on term loan | 1,300,000 | 100,000 | 1,300,000 | 1,600,000 | |||
Non-cash interest expense | 300,000 | $ 0 | 300,000 | $ 600,000 | |||
Senior Loan Agreement [Member] | Contra-Liability [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Final payment fee | $ 2,500,000 | $ 2,500,000 |
Debt - Summary of Composition o
Debt - Summary of Composition of Debt (Detail) - Senior Loan Agreement [Member] $ in Thousands | Sep. 30, 2023 USD ($) |
Debt Instrument [Line Items] | |
Gross proceeds | $ 50,000 |
Accrued final payment fee | 2,500 |
Unamortized debt discount and issuance costs | (10,099) |
Total short-term debt, net | $ 42,401 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||||
Aug. 24, 2023 | Jul. 21, 2023 | Feb. 28, 2023 | Aug. 31, 2020 | Nov. 30, 2019 | Sep. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2023 | Dec. 31, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Total unrecognized compensation related to unvested stock options | $ 13.1 | $ 13.1 | |||||||
Weighted-average stock option recognize period | 2 years 8 months 12 days | ||||||||
Common stock, shares authorized | 200,000,000 | 200,000,000 | 200,000,000 | ||||||
Common stock, par value | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||||||
Number of common shares sold | 750,000 | ||||||||
Shares Issued, Price Per Share | $ 6.75 | ||||||||
Restricted shares not issued | 349,000 | ||||||||
Pre Funded Warrant [Member] | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Warrant issued to purchase company's common stock | 4,064,814 | 4,064,814 | 4,064,814 | ||||||
Warrant price (per share) | $ 6.7499 | $ 0.0001 | $ 0.0001 | ||||||
Underwritten Offering [Member] | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Number of common shares sold | 750,000 | ||||||||
Shares Issued, Price Per Share | $ 6.75 | ||||||||
Sale of stock consideration | $ 30.3 | ||||||||
Underwritten Offering [Member] | Pre Funded Warrant [Member] | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Warrant issued to purchase company's common stock | 4,064,814 | ||||||||
Restricted Stock Units (RSUs) [Member] | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Weighted-average stock option recognize period | 6 months | ||||||||
Number of Shares, Granted | 698,000 | ||||||||
Stock vesting period | 1 year | ||||||||
Compensation expense | $ 8.2 | $ 8.2 | |||||||
Remaining unrecognized compensation related to nonvested restricted stock units | $ 2.1 | $ 2.1 | |||||||
Nonvested, Number of Shares, Forfeited | 125,000 | 125,000 | 0 | ||||||
Restricted Stock Units (RSUs) [Member] | Executive Officers [Member] | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Number of Shares, Granted | 250,000 | 300,000 | 698,000 | ||||||
Restricted Stock Units (RSUs) [Member] | One Year Anniversary [Member] | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Percentage of stock subject to vesting (as a percent) | 50% | ||||||||
Restricted Stock Units (RSUs) [Member] | New Drug Application [Member] | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Percentage of stock subject to vesting (as a percent) | 50% | 50% | |||||||
Restricted Stock Units (RSUs) [Member] | YCANTH [Member] | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Percentage of stock subject to vesting (as a percent) | 50% |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Company's Outstanding Warrants (Detail) - $ / shares | Sep. 30, 2023 | Feb. 28, 2023 |
Pre-funded warrants pursuant to common stock issuance [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Number of warrants | 4,064,814 | 4,064,814 |
Exercise Price | $ 0.0001 | $ 6.7499 |
Warrants issued with OrbiMed debt facility [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Number of warrants | 518,551 | |
Exercise Price | $ 6.0264 | |
Expiration Date | Jul. 25, 2033 |
Stockholders' Equity - Schedule
Stockholders' Equity - Schedule of Stock Based Compensation Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation | $ 9,663 | $ 1,413 | $ 12,301 | $ 3,814 |
Selling, General and Administrative Expenses [Member] | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation | 8,438 | 1,064 | 10,223 | 2,709 |
Research and Development [Member] | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total stock-based compensation | $ 1,225 | $ 349 | $ 2,078 | $ 1,105 |
Stockholders' Equity - Summar_2
Stockholders' Equity - Summary of Stock Option Activity (Detail) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2023 | Dec. 31, 2022 | |
Share-Based Payment Arrangement, Additional Disclosure [Abstract] | ||
Number of shares, Outstanding Beginning Balance | 3,932,779 | |
Number of shares, Granted | 1,578,836 | |
Number of shares, Exercised | (8,000) | |
Number of shares, Forfeited and Expired | (6,600) | |
Number of shares, Outstanding Ending Balance | 5,497,015 | 3,932,779 |
Number of shares, Options vested and exercisable Ending Balance | 2,898,680 | |
Weighted average exercise price, Outstanding Beginning Balance | $ 8.99 | |
Weighted average exercise price, Granted | 6.66 | |
Weighted average exercise price, Exercised | 0.9 | |
Weighted average exercise price, Forfeited and Expired | 5.13 | |
Weighted average exercise price, Outstanding Ending Balance | 8.34 | $ 8.99 |
Weighted average exercise price, Options vested and exercisable Ending Balance | $ 9.12 | |
Weighted average remaining contractual life (in years), Outstanding | 7 years 4 months 24 days | 7 years 9 months 18 days |
Weighted average remaining contractual life (in years), Options vested and exercisable | 6 years 1 month 6 days | |
Aggregate intrinsic value, Outstanding | $ 455,190 | $ 3,952,803 |
Aggregate intrinsic value, Options vested and exercisable Ending Balance | $ 245,112 |
Stockholders' Equity - Summar_3
Stockholders' Equity - Summary of Non-vested RSUs Activities (Detail) - Restricted Stock Units (RSUs) [Member] - $ / shares | 1 Months Ended | 9 Months Ended | |
Aug. 31, 2020 | Nov. 30, 2019 | Sep. 30, 2023 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Nonvested, Number of Shares, Beginning Balance | 425,000 | ||
Nonvested, Number of Shares, Granted | 698,000 | ||
Nonvested, Number of Shares, Vested | (561,500) | ||
Nonvested, Number of Shares, Forfeitures | (125,000) | (125,000) | 0 |
Nonvested, Number of Shares, Ending Balance | 561,500 | ||
Nonvested, Weighted Average Grant Date Fair Value, Beginning Balance | $ 11.68 | ||
Nonvested, Weighted Average Grant Date Fair Value, Granted | 7.58 | ||
Nonvested, Weighted Average Grant Date Fair Value, Forfeitures | 0 | ||
Non-vested, Weighted average grant date fair value, Vested | 9.13 | ||
Nonvested, Weighted Average Grant Date Fair Value, Ending Balance | $ 9.13 |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | |||||
Jul. 21, 2023 | Oct. 01, 2019 | Dec. 02, 2015 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Related Party Transaction [Line Items] | |||||||
Fee Per Eligible Patient | $ 15,000,000 | ||||||
Research and Development Expense | $ 4,500,000 | $ 6,510,000 | $ 2,780,000 | 14,975,000 | $ 9,170,000 | ||
Pbm Capital Group Llc [Member] | |||||||
Related Party Transaction [Line Items] | |||||||
Services agreement initial term | 12 months | ||||||
Expenses incurred under services agreement | 15,000 | 20,000 | 45,000 | ||||
Due to related party | 5,000 | 5,000 | |||||
Pbm Capital Group Llc [Member] | Amended Service Agreement [Member] | |||||||
Related Party Transaction [Line Items] | |||||||
Monthly management fee payable | $ 5,000 | ||||||
Pbm Capital Group Llc [Member] | General and Administrative [Member] | |||||||
Related Party Transaction [Line Items] | |||||||
Expenses incurred under services agreement | 9,000 | 12,000 | 27,000 | ||||
Pbm Capital Group Llc [Member] | Research and Development [Member] | |||||||
Related Party Transaction [Line Items] | |||||||
Expenses incurred under services agreement | $ 6,000 | $ 8,000 | 18,000 | ||||
Clinical Enrollment LLC [Member] | |||||||
Related Party Transaction [Line Items] | |||||||
Development Fee Compensation | 30,000,000 | ||||||
Research and Development Expense | $ 100,000 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) $ in Millions | 9 Months Ended | ||
Sep. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Product Liability Contingency [Line Items] | |||
Prepaid expense | $ 1.5 | ||
Crude Cantharidin Material [Member] | |||
Product Liability Contingency [Line Items] | |||
Purchase agreement term | 5 years | ||
Purchase Commitment | $ 0.7 | 0.7 | $ 0.8 |
Purchase commitment prepayment | $ 0.1 | $ 0.7 | $ 0.8 |
License and Collaboration Agr_2
License and Collaboration Agreements - Additional Information (Detail) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||||||
Jul. 21, 2023 | Jul. 25, 2022 | Mar. 17, 2021 | May 31, 2022 | Apr. 30, 2021 | Feb. 28, 2021 | Dec. 31, 2020 | Aug. 31, 2020 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
License And Collaboration Agreements [Line Items] | ||||||||||||||
Research and development expense | $ 4,500 | $ 6,510 | $ 2,780 | $ 14,975 | $ 9,170 | |||||||||
Ltyix [Member] | ||||||||||||||
License And Collaboration Agreements [Line Items] | ||||||||||||||
Payments upon achievements of milestone | $ 111,000 | |||||||||||||
One time up front license fee | $ 1,000 | $ 2,300 | $ 300 | |||||||||||
Research and development expense | 1,000 | $ 2,300 | ||||||||||||
Percentage of royalty income shared | 50% | |||||||||||||
Torii Agreement [Member] | Torii [Member] | ||||||||||||||
License And Collaboration Agreements [Line Items] | ||||||||||||||
Received payment | $ 11,500 | $ 500 | ||||||||||||
Payments upon achievements of milestone | 50,000 | 50,000 | ||||||||||||
Billed collaboration revenue | $ 100 | $ 300 | $ 300 | $ 1,000 | ||||||||||
Torii Agreement [Member] | Torii [Member] | License Revenue [Member] | ||||||||||||||
License And Collaboration Agreements [Line Items] | ||||||||||||||
Milestone payment recognized | $ 8,000 | |||||||||||||
Torii Agreement [Member] | Torii [Member] | Minimum [Member] | ||||||||||||||
License And Collaboration Agreements [Line Items] | ||||||||||||||
Mid Percentage of transfer price payments for supply of product net sales | 30% | |||||||||||||
Torii Agreement [Member] | Torii [Member] | Maximum [Member] | ||||||||||||||
License And Collaboration Agreements [Line Items] | ||||||||||||||
Mid Percentage of transfer price payments for supply of product net sales | 40% |
Subsequent Events - Additional
Subsequent Events - Additional Information (Details) - USD ($) $ / shares in Units, $ in Millions | Jul. 26, 2023 | Jul. 11, 2022 |
Subsequent Event [Line Items] | ||
Cash, cash equivalents and marketable securities and restricted cash | $ 40 | |
Prepayment of debt and fee | $ 43.8 | |
Available on or prior to June 30, 2024 | ||
Subsequent Event [Line Items] | ||
Remaining Commitment Amount | $ 25 | |
Available on or prior to December 31, 2024 | ||
Subsequent Event [Line Items] | ||
Remaining Commitment Amount | 30 | |
Available on or prior to March 31, 2025 | ||
Subsequent Event [Line Items] | ||
Remaining Commitment Amount | 10 | |
Available on or prior to June 30, 2025 | ||
Subsequent Event [Line Items] | ||
Remaining Commitment Amount | 10 | |
Loan Facility [Member] | ||
Subsequent Event [Line Items] | ||
Credit facility, maximum borrowing capacity | 125 | |
Initial Commitment Amount | $ 50 | |
Loans, maturity date | Jul. 26, 2028 | |
Net proceeds after payment of certain fees and transaction related expenses | $ 44.1 | |
Loan Facility [Member] | Available on or prior to June 30, 2024 | ||
Subsequent Event [Line Items] | ||
Remaining Commitment Amount | 25 | |
Loan Facility [Member] | Available on or prior to December 31, 2024 | ||
Subsequent Event [Line Items] | ||
Remaining Commitment Amount | 30 | |
Loan Facility [Member] | Available on or prior to March 31, 2025 | ||
Subsequent Event [Line Items] | ||
Remaining Commitment Amount | 10 | |
Loan Facility [Member] | Available on or prior to June 30, 2025 | ||
Subsequent Event [Line Items] | ||
Remaining Commitment Amount | $ 10 | |
SOFR | ||
Subsequent Event [Line Items] | ||
Interest rate (as a percent) | 4% | |
Loans, interest rate | 8% | |
Interest rate (as a percent) | 4% | |
Common Stock [Member] | ||
Subsequent Event [Line Items] | ||
Number of warrants | 518,551 | |
Warrant term | 10 years | |
Warrant price (per share) | $ 6.0264 |