Cover
Cover - shares | 9 Months Ended | |
Sep. 30, 2023 | Nov. 08, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2023 | |
Document Transition Report | false | |
Entity File Number | 001-39311 | |
Entity Registrant Name | POINT BIOPHARMA GLOBAL INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 85-0800493 | |
Entity Address, Address Line One | 4850 West 78th Street | |
Entity Address, City or Town | Indianapolis, | |
Entity Address, State or Province | IN | |
Entity Address, Postal Zip Code | 46268 | |
City Area Code | 317 | |
Local Phone Number | 543-9957 | |
Title of 12(b) Security | Common Stock | |
Trading Symbol | PNT | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 106,569,231 | |
Entity Central Index Key | 0001811764 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false |
Interim Condensed Consolidated
Interim Condensed Consolidated Balance Sheets - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets | ||
Cash and cash equivalents | $ 21,607,412 | $ 286,428,371 |
Short-term investments | 317,555,936 | 238,783,470 |
Prepaid expenses and other current assets | 9,901,729 | 5,610,889 |
Income taxes receivable | 4,181,469 | 0 |
Total current assets | 353,246,546 | 530,822,730 |
Non-current assets | ||
Long-term investments | 59,793,161 | 16,119,430 |
Note receivable | 5,116,667 | 0 |
Property, plant and equipment, net | 54,042,353 | 31,380,576 |
Operating lease right-of-use asset | 5,505,693 | 0 |
Total non-current assets | 124,457,874 | 47,500,006 |
Total assets | 477,704,420 | 578,322,736 |
Current liabilities | ||
Accounts payable | 8,886,750 | 7,703,150 |
Accrued liabilities | 14,529,354 | 19,094,454 |
Deferred revenue | 12,586,443 | 23,242,290 |
Income taxes payable | 736,729 | 29,698,546 |
Finance lease current liability | 987,018 | 0 |
Operating lease current liability | 939,983 | 0 |
Total current liabilities | 38,666,277 | 79,738,440 |
Deferred revenue, net of current portion | 3,720,881 | 10,178,147 |
Long-term income taxes payable | 2,389,109 | 1,452,356 |
Finance lease liability, net of current portion | 4,093,202 | 0 |
Operating lease liability, net of current portion | 4,642,565 | 0 |
Total liabilities | 53,512,034 | 91,368,943 |
Commitments and contingencies (Note 12) | ||
Stockholders’ equity | ||
Common Stock, par value $0.0001 per share, 430,000,000 authorized, 105,765,954 and 105,649,741 issued and outstanding as of September 30, 2023 and December 31, 2022, respectively | 10,576 | 10,565 |
Additional paid-in capital | 453,319,762 | 448,391,574 |
(Accumulated deficit) Retained earnings | (27,707,358) | 39,008,505 |
Accumulated other comprehensive loss | (1,430,594) | (456,851) |
Total stockholders’ equity | 424,192,386 | 486,953,793 |
Total liabilities and stockholders’ equity | $ 477,704,420 | $ 578,322,736 |
Interim Condensed Consolidate_2
Interim Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Common shares, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, authorized (in shares) | 430,000,000 | 430,000,000 |
Common stock, shares issued (in shares) | 105,765,954 | 105,649,741 |
Common stock, shares outstanding (in shares) | 105,765,954 | 105,649,741 |
Unaudited Interim Condensed Con
Unaudited Interim Condensed Consolidated Statements of Operations - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Revenue | ||||
Revenue | $ 2,789,993 | $ 0 | $ 17,113,113 | $ 0 |
Operating expenses | ||||
Research and development | 26,910,286 | 20,797,406 | 85,097,331 | 54,112,136 |
General and administrative | 5,505,869 | 3,839,626 | 15,604,401 | 11,727,969 |
Total operating expenses | 32,416,155 | 24,637,032 | 100,701,732 | 65,840,105 |
Loss from operations | (29,626,162) | (24,637,032) | (83,588,619) | (65,840,105) |
Other income (expenses) | ||||
Investment income | 5,617,736 | 1,048,254 | 16,717,703 | 1,605,927 |
Foreign currency gain (loss) | 105,522 | (243,791) | (133,438) | (287,691) |
Total other income (expenses) | 5,723,258 | 804,463 | 16,584,265 | 1,318,236 |
Loss before income taxes | (23,902,904) | (23,832,569) | (67,004,354) | (64,521,869) |
Income tax (provision) benefit | (871,449) | (180,500) | 288,491 | (452,021) |
Net loss | $ (24,774,353) | $ (24,013,069) | $ (66,715,863) | $ (64,973,890) |
Net loss per basic and diluted common share: | ||||
Basic net loss per common share (in dollars per share) | $ (0.23) | $ (0.26) | $ (0.63) | $ (0.71) |
Diluted net loss per common share (in dollars per share) | $ (0.23) | $ (0.26) | $ (0.63) | $ (0.71) |
Basic weighted average common shares outstanding (in shares) | 105,765,954 | 92,401,484 | 105,717,330 | 90,891,031 |
Diluted weighted average common shares outstanding (in shares) | 105,765,954 | 92,401,484 | 105,717,330 | 90,891,031 |
Unaudited Condensed Consolidate
Unaudited Condensed Consolidated Statements of Comprehensive Loss - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (24,774,353) | $ (24,013,069) | $ (66,715,863) | $ (64,973,890) |
Other comprehensive loss, net of tax | ||||
Net unrealized loss on available-for-sale debt securities | (361,611) | (266,320) | (973,743) | (608,698) |
Total comprehensive loss | $ (25,135,964) | $ (24,279,389) | $ (67,689,606) | $ (65,582,588) |
Unaudited Interim Condensed C_2
Unaudited Interim Condensed Consolidated Statements of Stockholders' Equity - USD ($) | Total | Common Stock | Additional Paid-in Capital | Retained Earnings (Accumulated Deficit) | Accumulated Other Comprehensive Loss |
Beginning balance (in shares) at Dec. 31, 2021 | 90,121,794 | ||||
Beginning balance at Dec. 31, 2021 | $ 255,213,086 | $ 9,012 | $ 314,488,782 | $ (59,284,708) | $ 0 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of shares of common stock in connection with stock option exercises (in shares) | 678 | ||||
Issuance of shares of Common Stock in connection with stock option exercises | 942 | 942 | |||
Stock-based compensation | 440,450 | 440,450 | |||
Net loss | (16,380,574) | (16,380,574) | |||
Ending balance (in shares) at Mar. 31, 2022 | 90,122,472 | ||||
Ending balance at Mar. 31, 2022 | 239,273,904 | $ 9,012 | 314,930,174 | (75,665,282) | 0 |
Beginning balance (in shares) at Dec. 31, 2021 | 90,121,794 | ||||
Beginning balance at Dec. 31, 2021 | 255,213,086 | $ 9,012 | 314,488,782 | (59,284,708) | 0 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of shares of Common Stock, net of direct and incremental costs (in shares) | 13,933,168 | ||||
Net loss | (64,973,890) | ||||
Ending balance (in shares) at Sep. 30, 2022 | 104,054,962 | ||||
Ending balance at Sep. 30, 2022 | 309,079,832 | $ 10,405 | 433,936,723 | (124,258,598) | (608,698) |
Beginning balance (in shares) at Mar. 31, 2022 | 90,122,472 | ||||
Beginning balance at Mar. 31, 2022 | 239,273,904 | $ 9,012 | 314,930,174 | (75,665,282) | 0 |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of shares of common stock in connection with stock option exercises (in shares) | 2,490 | ||||
Issuance of shares of Common Stock in connection with stock option exercises | 3,461 | 3,461 | |||
Stock-based compensation | 1,027,563 | 1,027,563 | |||
Net loss | (24,580,247) | (24,580,247) | |||
Other comprehensive income (loss), net of tax | (342,378) | (342,378) | |||
Ending balance (in shares) at Jun. 30, 2022 | 90,124,962 | ||||
Ending balance at Jun. 30, 2022 | 215,382,303 | $ 9,012 | 315,961,198 | (100,245,529) | (342,378) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of shares of Common Stock, net of direct and incremental costs (in shares) | 13,900,000 | ||||
Issuance of shares of Common Stock, net of direct and incremental costs | 116,856,162 | $ 1,390 | 116,854,772 | ||
Issuance of shares of common stock in connection with stock option exercises (in shares) | 30,000 | ||||
Issuance of shares of Common Stock in connection with stock option exercises | 41,700 | $ 3 | 41,697 | ||
Stock-based compensation | 1,079,056 | 1,079,056 | |||
Net loss | (24,013,069) | (24,013,069) | |||
Other comprehensive income (loss), net of tax | (266,320) | (266,320) | |||
Ending balance (in shares) at Sep. 30, 2022 | 104,054,962 | ||||
Ending balance at Sep. 30, 2022 | $ 309,079,832 | $ 10,405 | 433,936,723 | (124,258,598) | (608,698) |
Beginning balance (in shares) at Dec. 31, 2022 | 105,649,741 | 105,649,741 | |||
Beginning balance at Dec. 31, 2022 | $ 486,953,793 | $ 10,565 | 448,391,574 | 39,008,505 | (456,851) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of shares of common stock in connection with stock option exercises (in shares) | 32,936 | ||||
Issuance of shares of Common Stock in connection with stock option exercises | 145,864 | $ 3 | 145,861 | ||
Stock-based compensation | 1,009,496 | 1,009,496 | |||
Net loss | (16,530,671) | (16,530,671) | |||
Other comprehensive income (loss), net of tax | 201,294 | 201,294 | |||
Ending balance (in shares) at Mar. 31, 2023 | 105,682,677 | ||||
Ending balance at Mar. 31, 2023 | $ 471,779,776 | $ 10,568 | 449,546,931 | 22,477,834 | (255,557) |
Beginning balance (in shares) at Dec. 31, 2022 | 105,649,741 | 105,649,741 | |||
Beginning balance at Dec. 31, 2022 | $ 486,953,793 | $ 10,565 | 448,391,574 | 39,008,505 | (456,851) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ (66,715,863) | ||||
Ending balance (in shares) at Sep. 30, 2023 | 105,765,954 | 105,765,954 | |||
Ending balance at Sep. 30, 2023 | $ 424,192,386 | $ 10,576 | 453,319,762 | (27,707,358) | (1,430,594) |
Beginning balance (in shares) at Mar. 31, 2023 | 105,682,677 | ||||
Beginning balance at Mar. 31, 2023 | 471,779,776 | $ 10,568 | 449,546,931 | 22,477,834 | (255,557) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of shares of common stock in connection with stock option exercises (in shares) | 83,277 | ||||
Issuance of shares of Common Stock in connection with stock option exercises | 186,058 | $ 8 | 186,050 | ||
Stock-based compensation | 1,710,349 | 1,710,349 | |||
Net loss | (25,410,839) | (25,410,839) | |||
Other comprehensive income (loss), net of tax | (813,426) | (813,426) | |||
Ending balance (in shares) at Jun. 30, 2023 | 105,765,954 | ||||
Ending balance at Jun. 30, 2023 | $ 447,451,918 | $ 10,576 | 451,443,330 | (2,933,005) | (1,068,983) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of shares of Common Stock, net of direct and incremental costs (in shares) | 0 | ||||
Stock-based compensation | $ 1,876,432 | 1,876,432 | |||
Net loss | (24,774,353) | (24,774,353) | |||
Other comprehensive income (loss), net of tax | $ (361,611) | (361,611) | |||
Ending balance (in shares) at Sep. 30, 2023 | 105,765,954 | 105,765,954 | |||
Ending balance at Sep. 30, 2023 | $ 424,192,386 | $ 10,576 | $ 453,319,762 | $ (27,707,358) | $ (1,430,594) |
Unaudited Interim Condensed C_3
Unaudited Interim Condensed Consolidated Statements of Cash Flows - USD ($) | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Cash flows from operating activities | ||
Net loss: | $ (66,715,863) | $ (64,973,890) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation on property, plant and equipment | 2,186,253 | 980,995 |
Deferred and non-current income taxes | 936,753 | (65,592) |
Stock-based compensation expense | 4,596,277 | 2,547,069 |
Non-cash lease expense | 196,772 | 0 |
Amortization of premiums (accretion of discounts) on investments, net | (9,457,635) | (435,238) |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 709,160 | 318,586 |
Accounts payable | (1,060,594) | 1,261,082 |
Accrued liabilities | (4,534,719) | 6,926,449 |
Deferred revenue | (17,113,113) | 0 |
Income taxes receivable and payable | (33,143,286) | 110,745 |
Operating lease liabilities | (62,014) | 0 |
Change in accrued interest and dividends within investments | (1,397,490) | (67,483) |
Net cash used in operating activities | (124,859,499) | (53,397,277) |
Cash flows from investing activities | ||
Purchase of investments, net of sales and maturities | (117,757,923) | (165,841,488) |
Purchase of property, plant and equipment | (17,249,510) | (10,696,365) |
Purchase of note receivable | (5,000,000) | 0 |
Net cash used in investing activities | (140,007,433) | (176,537,853) |
Cash flows from financing activities | ||
Issuance of shares of Common Stock in connection with stock option exercises | 331,922 | 46,103 |
Payments on finance lease | (285,949) | 0 |
Issuance of shares of Common Stock, net of direct and incremental costs paid | 0 | 116,856,162 |
Net cash provided by financing activities | 45,973 | 116,902,265 |
Net decrease in cash and cash equivalents | (264,820,959) | (113,032,865) |
Cash and cash equivalents, beginning of period | 286,428,371 | 238,815,991 |
Cash and cash equivalents, end of period | 21,607,412 | 125,783,126 |
Supplemental disclosure of cash flow information: | ||
Cash paid for income taxes | 31,924,135 | 411,424 |
Non-cash investment activities: | ||
Receivable for investment maturities | 5,000,000 | 0 |
Purchase of property, plant and equipment recorded in accounts payable and accrued liabilities | $ 3,623,314 | $ 1,142,278 |
Nature of business
Nature of business | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of business | Nature of business POINT Biopharma Global Inc., together with its consolidated subsidiaries ("POINT" or the “Company”), is a globally focused radiopharmaceutical company building a platform for the clinical development and commercialization of radioligands that fight cancer. The Company was founded on a mission to make radioligand therapy applicable to more cancers and available to more people, thereby improving the lives of cancer patients and their families everywhere. The Company has four wholly-owned subsidiaries, POINT Biopharma Inc., POINT Biopharma USA Inc. and West 78 th Street, LLC, each located in the U.S., and POINT Biopharma Corp., located in Canada (collectively the "Subsidiaries"). The Company’s headquarters is located at 4850 West 78 th Street, Indianapolis, Indiana, 46268. |
Summary of significant accounti
Summary of significant accounting policies | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Summary of significant accounting policies | Summary of significant accounting policies Basis of presentation The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 270, Interim Reporting and include the accounts of the Company and the Subsidiaries, for financial information and pursuant to the rules and regulations of the Securities and Exchange Commission ("SEC"). Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the United States of America (“GAAP”). All intercompany accounts and transactions have been eliminated in consolidation. In the opinion of management, the unaudited interim condensed consolidated 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. Except as described below, the accounting policies and methods of computation applied in the unaudited interim condensed consolidated financial statements and related notes contained therein are consistent with those applied by the Company in its audited consolidated financial statements as of and for the year ended December 31, 2022 contained in our Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the SEC on March 27, 2023 (the “2022 Financial Statements”). These unaudited interim condensed consolidated financial statements should be read in conjunction with the 2022 Financial Statements. These unaudited interim condensed consolidated financial statements and accompanying notes have been prepared in accordance with the provisions of ASC Topic 205-40, Presentation of Financial Statements—Going Concern on the basis that the Company will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. COVID-19 Pandemic, macroeconomics and other geopolitical events The Company is currently operating in a period of significant economic uncertainty, resulting from, among other things, the impact of the COVID-19 pandemic, geopolitical tensions, such as the ongoing military conflict between Russia and Ukraine, the Israel-Palestine conflict and heightened tensions between China and Taiwan, trade uncertainty, including changes in tariffs, sanctions, international treaties, and other trade restrictions, rising inflation and interest rates, and uncertainty and liquidity concerns in the broader financial services industry, including those caused by certain recent banking failures. The Company is continuing to monitor the development and potential impact of these global economic and geopolitical events on its business and unaudited interim condensed consolidated financial statements. To date, the Company has not experienced any material business disruptions or incurred any impairment losses in the carrying values of its assets as a result of these events and it is not aware of any specific related event or circumstance that would require it to revise its estimates reflected in these unaudited interim condensed consolidated financial statements. However, estimates and assumptions about future events and their effects cannot be determined with certainty, and therefore, require the exercise of judgment; as a result, the Company’s estimates may change as new events occur and additional information is obtained. Risks and uncertainties Except for the upfront payment received pursuant to the Lantheus License Agreements (as defined in Note 3 below), the Company has incurred significant net losses and has funded operations primarily through equity financings. Operating losses and negative cash flows were incurred in the nine months ended September 30, 2023 and are expected to continue to be incurred in future periods. The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, successful discovery and development of its product candidates, regulatory approval of its product candidates, development by competitors of new technological innovations, dependence on key personnel, the ability to attract and retain qualified employees, protection of proprietary technology, compliance with governmental regulations, the impact of macroeconomic disruptions, such as those arising from public health crisis or military conflicts and adverse developments affecting the financial services industry, the ability to secure additional capital to fund operations and commercial success of its product candidates. Product candidates currently under development will require extensive preclinical and clinical testing and regulatory approval prior to commercialization. These efforts require significant amounts of capital, adequate personnel, and infrastructure and extensive compliance-reporting capabilities. Even if the Company’s drug development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales. The Company also has a number of risks and uncertainties related to the Offer and Merger described in Note 16. These risks and uncertainties are described in more detail in Part II. Item 1A. “Risk Factors” starting on page 34. Use of estimates The preparation of the unaudited interim condensed consolidated financial statements in conformity with GAAP requires management to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, related disclosure of contingent assets and liabilities at the date of the unaudited interim condensed consolidated financial statements, and the reported amounts of expenses for the periods presented. Significant estimates and assumptions reflected in these unaudited interim condensed consolidated financial statements include, but are not limited to, the allocation of consideration and the recognition of revenues in respect of the performance obligations under the Lantheus License Agreements, the accrual of research and development expenses, incremental borrowing rates determined in connection with finance and operating lease obligations, the valuations of stock options, the expected recoverability of and the estimated useful lives of our long-lived assets. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances. On an ongoing basis, management evaluates its estimates when there are changes in circumstances, facts and experiences. Changes in estimates are recorded in the period in which they become known. Actual results may differ from those estimates or assumptions. Leases The Company accounts for leases in accordance with ASC Topic 842, Leases ("ASC 842"). At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present. The Company has elected not to recognize leases with an original term of one year or less in the consolidated balance sheets. The Company has also elected to account for the lease and non-lease components as a combined lease component for its current lease portfolio. Right-of-use assets and lease liabilities are recognized at the commencement date based on the present value of lease payments over the lease term. Options to renew or early terminate a lease are included in the initial lease term of a lease when there is reasonable certainty that the option will be applied. ASC 842 requires a lessee to discount its unpaid lease payments using the interest rate implicit in the lease or, if that rate cannot be readily determined, its incremental borrowing rate. The Company's incremental borrowing rate is determined using a secured borrowing rate for the same currency and term as the associated lease in a similar economic environment. Lease expense for operating leases is recognized on a straight-line basis over the lease term and included in operating expenses in the condensed consolidated statements of operations and comprehensive loss. Recent accounting pronouncements The Company has evaluated accounting pronouncements recently issued but not yet adopted and believes that the accounting pronouncements currently do not apply to the Company’s operations and are not expected to have a material impact on the Company’s unaudited interim condensed consolidated financial statements or disclosures. |
Revenue
Revenue | 9 Months Ended |
Sep. 30, 2023 | |
Revenue from Contract with Customer [Abstract] | |
Revenue | RevenueIn November 2022, POINT announced strategic collaboration and exclusive license agreements with Lantheus Holdings Inc. ("Lantheus") for exclusive worldwide rights for POINT's programs in prostate cancer (PNT2002) and neuroendocrine tumors (PNT2003), excluding certain territories (Japan, South Korea, Singapore, Indonesia, and China including Hong Kong, Macau and Taiwan) (the "PNT2002 Agreement" and the "PNT2003 Agreement", respectively, and collectively the "Lantheus License Agreements"). The collaboration pairs POINT's expertise in next generation radioligand development and manufacturing with Lantheus’ commercial leadership in Prostate-Specific Membrane Antigen ("PSMA") PET and radiopharmaceuticals. In December 2022, closing conditions for the Lantheus transaction, including antitrust clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (as amended, the "HSR Act"), were satisfied. POINT received a $250.0 million upfront payment under the PNT2002 Agreement and will receive an additional payment of up to $250.0 million upon U.S. regulatory approval. In addition, once certain return on investment financial thresholds have been achieved and other conditions satisfied, POINT will be eligible to receive royalties of 20% on all net sales (prior to which there is a period of sales in which the royalty may be based on only a portion of the gross profit), and contingent upon the satisfaction of certain net sales milestones, additional payments of up to $1.3 billion. POINT received a $10.0 million upfront payment under the PNT2003 Agreement, and will receive up to an additional $30.0 million upon U.S. regulatory approval. The PNT2003 Agreement also provides that POINT will receive royalties of 15% on net sales and, contingent upon the satisfaction of certain net sales milestones, an additional payment of up to $275.0 million. In connection with the PNT2002 Agreement, the Company is responsible for completing the Company's multi-center, randomized, open label phase 3 S tudy evaluating metastatic castration-resistant P rostate cancer using 177 L u-PNT2002 PSMA therapy A fter S econd-line H ormonal treatment (“SPLASH") trial and the parties will work together to file the New Drug Application (“NDA”), with the costs incurred in connection with the U.S. Food and Drug Administration ("FDA") submission being borne by Lantheus. Thereafter, Lantheus will be responsible for all additional clinical and regulatory costs in the U.S., as well as all costs for development, clinical trials and regulatory approval in the rest of its territories outside the U.S., except Asia. To determine the appropriate amount of revenue to be recognized under ASC Topic 606, Revenue from Contracts with Customers , the Company performs the following steps: (i) identify the promised goods or services in the contract, (ii) determine whether the promised goods or services are performance obligations, including whether they are distinct in the context of the contract, (iii) measure the transaction price, including the constraint on variable consideration, (iv) allocate the transaction price to the performance obligations and (v) recognize revenue when (or as) the Company satisfies each performance obligation. In connection with the PNT2002 Agreement, the Company identified the following performance conditions: (i) the license it conveyed to Lantheus with respect to certain intellectual property, (ii) service provided to complete the SPLASH trial, support the NDA submission and participate in joint steering activities and (iii) manufacturing activities. The Company determined the transaction price under ASC Topic 606 at the inception of the PNT2002 Agreement to be the $250.0 million upfront payment and has allocated this to the first two performance obligations based on a relative standalone selling price basis. The standalone selling prices for the first two performance obligations were determined using the adjusted market assessment approach and the expected cost plus a margin assessment approach, respectively. The Company concluded that variable consideration associated with the product manufacturing relates solely to the manufacturing activities performance obligation on the basis that it believes that the expected margin associated with this consideration is in line with market standards and specifically relates to the Company's efforts to satisfy its manufacturing obligations. In connection with the PNT2003 Agreement, the Company identified the following performance conditions: (i) the license it conveyed to Lantheus with respect to certain intellectual property, (ii) service provided to complete the necessary submissions for regulatory approval and participate in joint steering activities and (iii) manufacturing activities. The Company determined the transaction price under ASC Topic 606 at the inception of the PNT2003 Agreement to be the $10.0 million upfront payment and has allocated this to the first two performance obligations based on a relative standalone selling price basis. The standalone selling prices for the first two performance obligations were determined using the adjusted market assessment approach and the expected cost plus a margin assessment approach, respectively. The Company concluded that variable consideration associated with the product manufacturing relates solely to the manufacturing activities performance obligation on the basis that it believes that the expected margin associated with this consideration is in line with market standards and specifically relates to the Company's efforts to satisfy its manufacturing obligations. The Company does not include variable consideration to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will occur. Variable consideration in the PNT2002 Agreement and PNT2003 Agreement consists of: • Potential future regulatory milestone payments. The Company concluded that this variable consideration is constrained considering that achievement of the milestones is outside its control and contingent upon the future success of clinical trials and regulatory approval by the FDA and in respect of other territories outside the U.S. • Potential future milestone payments in connection with certain sales targets as well as any future royalties. The Company concluded that these payments qualify for the royalty exception. Under the royalty exception, sales-based royalties are recognized at the later of when (1) the subsequent sale or usage occurs or (2) the performance obligation to which some or all of the sales- or usage-based royalty has been allocated is satisfied (in whole or in part). That is, an entity does not estimate the amount of a sales-based royalty at contract inception; rather, revenue would be recognized when the subsequent sales occur (under the assumption that the associated performance obligation has been satisfied or partially satisfied). • Potential payments for the manufacturing and supply of commercial product. The Company concluded that this variable consideration is constrained as it is contingent upon future regulatory approvals and the execution of a manufacturing and supply agreement. The estimate of the Company’s variable consideration to be included in the transaction price is updated at each reporting date as a change in estimate. For the potential future regulatory milestone payments, the Company utilizes the most likely amount approach to determine the amounts recognized and timing of recognition. For the potential payments for manufacturing and supply of commercial product, the Company utilizes the expected value approach to determine the amounts recognized and timing of recognition. Once the constraint is removed, the milestone payments will be accounted for and allocated to the performance obligations. For the licenses conveyed to Lantheus, the Company recognized revenue upon execution and regulatory approval of the Lantheus License Agreements. The Company concluded that the licenses represent that of functional intellectual property as each has significant standalone functionality and derives a substantial portion of its utility from that standalone functionality. For the obligations to complete the SPLASH trial, support the NDA submission and participate in joint steering activities in connection with the PNT2002 Agreement as well as the obligations to complete the necessary submissions for regulatory approval and participate in joint steering activities for the PNT2003 Agreement, the Company recognizes revenue using the cost-to-cost method, which it concluded best depicts the transfer of control to the customer. Under the cost-to-cost method, the extent of progress towards completion is measured based on the ratio of actual costs incurred to the total estimated costs expected upon satisfying the identified performance obligation. Under this method, revenue is recorded as a percentage of the estimated transaction price based on the extent of progress towards completion. The following table presents the Company’s contract liabilities as of September 30, 2023 and December 31, 2022 : September 30, 2023 December 31, 2022 Deferred revenue Deferred revenue, current $ 12,586,443 $ 23,242,290 Deferred revenue, net of current portion 3,720,881 10,178,147 Total $ 16,307,324 $ 33,420,437 At inception of the Lantheus License Agreements, deferred revenue of $34.8 million was recognized in connection with future performance. During the three and nine months ended September 30, 2023, the Company recognized $2.8 million and $17.1 million in revenue for services performed (three and nine months ended September 30, 2022 — $nil and $nil, respectively). The current portion of deferred revenue reflects the Company’s estimate of the revenue it expects to recognize within the next 12 months. The Company expects to recognize the remainder of the deferred revenue balance in subsequent periods through the year ending December 31, 2028. No contract assets were recognized in connection with the Lantheus License Agreements, including costs incurred in obtaining the agreements. |
Cash, cash equivalents and inve
Cash, cash equivalents and investments | 9 Months Ended |
Sep. 30, 2023 | |
Cash and Cash Equivalents [Abstract] | |
Cash, cash equivalents and investments | Cash, cash equivalents and investments Cash, cash equivalents and investments consisted of the following: As of September 30, 2023 As of December 31, 2022 Cash $ 11,446,728 $ 12,429,627 Cash equivalents: Money market funds 6,852,616 273,998,744 Commercial paper 3,308,068 — Total cash and cash equivalents 21,607,412 286,428,371 Short-term investments Commercial paper 107,567,350 115,156,455 Corporate bonds 93,787,733 45,219,042 U.S. Government agency debt securities 35,942,645 42,577,762 Asset backed securities 80,258,208 35,830,211 Total short-term investments 317,555,936 238,783,470 Long-term investments U.S. Government agency debt securities 16,098,662 — Asset backed securities 8,634,828 16,119,430 Corporate bonds 35,059,671 — Total long-term investments 59,793,161 16,119,430 Total cash, cash equivalents and investments $ 398,956,509 $ 541,331,271 Available-for-sale investments The amortized cost, gross unrealized gains, gross unrealized losses and fair value of available-for-sale investments by type of security as of September 30, 2023 were as follows: Amortized Cost Unrealized Gains Unrealized Losses Fair Value Current Non-current Commercial paper $ 107,597,155 $ 981 $ (30,786) $ 107,567,350 $ 107,567,350 $ — Corporate bonds 129,438,450 5,918 (596,964) 128,847,404 93,787,733 35,059,671 Asset backed securities 89,554,665 204 (661,833) 88,893,036 80,258,208 8,634,828 U.S. Government agency debt securities 52,186,023 — (144,716) 52,041,307 35,942,645 16,098,662 Total available-for-sale securities $ 378,776,293 $ 7,103 $ (1,434,299) $ 377,349,097 $ 317,555,936 $ 59,793,161 The amortized cost, gross unrealized gains, gross unrealized losses and fair value of available-for-sale investments by type of security as of December 31, 2022 were as follows: Amortized Cost Unrealized Gains Unrealized Losses Fair Value Current Non-current Commercial paper $ 115,156,455 $ — $ — $ 115,156,455 $ 115,156,455 $ — Asset backed securities 52,019,619 26,527 (96,505) 51,949,641 35,830,211 16,119,430 Corporate bonds 45,468,482 — (249,440) 45,219,042 45,219,042 — U.S. Government agency debt securities 42,715,195 — (137,433) 42,577,762 42,577,762 — Total available-for-sale securities $ 255,359,751 $ 26,527 $ (483,378) $ 254,902,900 $ 238,783,470 $ 16,119,430 The following table summarizes the fair value of available-for-sale investments based on stated contractual maturities as of September 30, 2023: Amortized Cost Fair Value Due within one year $ 318,607,866 $ 317,555,936 Due between one and five years 60,168,427 59,793,161 Total $ 378,776,293 $ 377,349,097 The following table summarizes the fair value of available-for-sale investments based on stated contractual maturities as of December 31, 2022: Amortized Cost Fair Value Maturing within one year $ 239,236,498 $ 238,783,470 Maturing between one and five years 16,123,253 16,119,430 Total $ 255,359,751 $ 254,902,900 The primary objective of our investment portfolio is to maintain safety of principal balances, provide sufficient levels of liquidity and enhance overall returns in an efficient manner with acceptable levels of risk. Our investment policy limits interest-bearing security investments to certain types of debt and money market instruments issued by institutions with primarily investment-grade credit ratings, and it places restrictions on maturities and concentration by asset class and issuer. During the three and nine months ended September 30, 2023, we had $611 of realized gains on available-for-sale investments. |
Fair value measurements
Fair value measurements | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair value measurements | Fair value measurements We measure fair value based on the prices that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Fair value measurements are based on a three-tier hierarchy that prioritizes the inputs used to measure fair value. These tiers include the following: Level 1: Quoted prices (unadjusted) in active markets for identical assets or liabilities that are accessible at the measurement date. The fair value hierarchy gives the highest priority to Level 1 inputs. Level 2: Observable prices that are based on inputs not quoted on active markets, but corroborated by market data. These inputs include quoted prices for similar assets or liabilities; quoted market prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Level 3: Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs. The following tables present information about the Company’s financial assets and liabilities as of September 30, 2023 and December 31, 2022, that are measured at fair value on a recurring basis and indicates the level of the fair value hierarchy used to determine such fair values: Level 1 Level 2 Level 3 Total September 30, 2023 Cash equivalents: Money market mutual fund $ 6,852,616 $ — $ — $ 6,852,616 Commercial paper — 3,308,068 — 3,308,068 Available-for-sale debt securities: Commercial paper — 107,567,350 — 107,567,350 Corporate bonds — 128,847,404 — 128,847,404 Asset backed securities — 88,893,036 — 88,893,036 U.S. Government agency debt securities 52,041,307 — — 52,041,307 Total $ 58,893,923 $ 328,615,858 $ — $ 387,509,781 Level 1 Level 2 Level 3 Total December 31, 2022 Cash equivalents: Money market mutual fund $ 273,998,744 $ — $ — $ 273,998,744 Commercial paper — — — — Available-for-sale debt securities: Commercial paper — 115,156,455 — 115,156,455 Asset backed securities — 51,949,641 — 51,949,641 Corporate bonds — 45,219,042 — 45,219,042 U.S. Government agency debt securities 42,577,762 — — 42,577,762 Total $ 316,576,506 $ 212,325,138 $ — $ 528,901,644 Certain of our available-for-sale debt securities, including U.S. Government agency debt securities, are valued using inputs observable in active markets for identical securities and are therefore classified as Level 1 within the fair value hierarchy. On May 7, 2023, POINT Biopharma Inc. entered into a Convertible Note Purchase Agreement (the "Convertible Note Agreement") with Ionetix Alpha Corporation ("Ionetix-α"), a subsidiary of IONETIX Corporation. On June 1, 2023, the Company purchased $5.0 million in unsecured promissory notes (the "Note Receivable") convertible into common stock of Ionetix-α at a conversion price that is calculated based on certain conditions as defined in the Convertible Note Agreement. Management assessed all features in the Convertible Note Agreement to determine embedded derivatives requiring bifurcation. In accordance with the Convertible Note Agreement, Ionetix-α has a voluntary redemption option, subject to certain terms and conditions, and may provide notice to the Company upon which the Company can elect to either redeem the Note Receivable at 150% of principal and interest outstanding or convert it into common stock of Ionetix-α. Management concluded that this put option meets the definition of a derivative and it is not clearly and closely related to the Note Receivable, thus requiring bifurcation from the host instrument and recognition at fair value. Further, management concluded the Note Receivable host instrument is to be classified as a loan receivable and therefore is measured at amortized cost but disclosure of fair value is required. Management determined the fair values of both the Note Receivable and the embedded derivative under Level 3 in the fair value hierarchy. Management concluded that the fair value of the Note Receivable as of September 30, 2023 approximated amortized cost and that the fair value of the embedded derivative was nil both at inception of the arrangement and on September 30, 2023. On September 29, 2023, POINT Biopharma Inc. entered into the Amendment of Convertible Note Purchase Agreement (the "Amendment"), whereby in connection with the Amendment, the Company and Ionetix-α agreed to accelerate the purchase of an additional $5.0 million of unsecured promissory notes subject to certain closing conditions. Those conditions were met and the additional purchase was made on October 2, 2023. See Note 16. We did not have any financial liabilities measured at fair value on a recurring basis as of September 30, 2023. The carrying values of the Company’s cash and cash equivalents, accounts payable and accrued liabilities approximate fair value due to their short maturities. There have been no transfers of assets or liabilities between the fair value measurement levels as of September 30, 2023. |
Prepaid expenses and other curr
Prepaid expenses and other current assets | 9 Months Ended |
Sep. 30, 2023 | |
Prepaid Expense and Other Assets, Current [Abstract] | |
Prepaid expenses and other current assets | Prepaid expenses and other current assets Prepaid expenses and other current assets consisted of the following: As of September 30, 2023 As of December 31, 2022 $ $ Prepaid clinical trial expenses 2,812,270 4,011,419 Prepaid insurance 1,390,347 1,310,314 Receivable on matured short-term investment 5,000,000 — Canadian harmonized sales tax receivable 206,326 60,222 Deposit on production equipment — 13,738 Other 492,786 215,196 Total 9,901,729 5,610,889 |
Property, plant and equipment,
Property, plant and equipment, net | 9 Months Ended |
Sep. 30, 2023 | |
Property, Plant and Equipment [Abstract] | |
Property, plant and equipment, net | Property, plant and equipment, net Property, plant and equipment, net consisted of the following: As of September 30, 2023 As of December 31, 2022 $ $ Land and building 19,992,990 18,163,962 Machinery and equipment 11,241,336 5,328,639 Property, plant and equipment, in development 19,827,730 8,434,384 Facility lease (Note 9) 5,384,707 — Furniture and fixtures 938,909 698,728 Computer equipment 237,963 149,892 57,623,635 32,775,605 Less: Accumulated depreciation (3,581,282) (1,395,029) Total 54,042,353 31,380,576 In July 2020, the Company purchased land and a building in Indianapolis, Indiana (which has been expanded to approximately 81,000 square feet) for the purpose of retrofitting the existing building into a state-of-the-art, Current Good Manufacturing Practices ("cGMP") compliant facility that will support the Company’s drug manufacturing operations. The Company commenced the manufacture of clinical supply in the Indianapolis manufacturing facility in January 2022. Construction continues on the facility to expand capacity. Property, plant and equipment that have finite lives are recorded at cost less accumulated depreciation and impairment losses. Depreciation is expensed from the month the particular asset is available for its intended use, using the straight-line method over the estimated useful life of such asset at the following rates, which in each case are intended to reduce the carrying value of the asset to the estimated residual value: Asset Category Estimated Useful Life Computer equipment 5 years Machinery and equipment 7 years Furniture and fixtures 7 years Facility lease 7 years Building 20 years |
Accrued liabilities
Accrued liabilities | 9 Months Ended |
Sep. 30, 2023 | |
Accrued Liabilities, Current [Abstract] | |
Accrued liabilities | Accrued liabilitiesAccrued liabilities consisted of the following: As of September 30, 2023 As of December 31, 2022 $ $ Accrued personnel costs 5,663,218 7,116,382 Accrued research and development costs 7,766,189 9,645,594 Accrued corporate legal fees and other professional services 907,019 2,068,793 Accrued costs for purchases of property, plant and equipment 75,360 105,741 Other accrued costs 117,568 157,944 Total 14,529,354 19,094,454 |
Leases
Leases | 9 Months Ended |
Sep. 30, 2023 | |
Leases [Abstract] | |
Leases | Leases Right-of-use assets and lease liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. ASC 842 requires a lessee to discount its unpaid lease payments using the interest rate implicit in the lease or, if that rate cannot be readily determined, its incremental borrowing rate. As an implicit interest rate was not readily determinable in the Company’s current portfolio of leases, the incremental borrowing rate was used based on the information available at the commencement date in determining the present value of lease payments. The Company has not incurred any material short-term lease costs or variable lease costs associated with its finance and operating leases. On February 2, 2023, POINT Biopharma Corp., entered into a Facility Agreement (the "UHN Agreement") with University Health Network (“UHN”), a not-for-profit corporation incorporated under the laws of Canada. Pursuant to the UHN Agreement, the Company was provided access to utilize a 7,700 square foot, licensed research and development space with cGMP manufacturing suites (the “Facility”), which the Company will use to develop and expand its pipeline of next-generation radioligands. The lease commencement date was determined to be April 1, 2023, the date upon which the Company was provided access to the Facility. The lease is accounted for as a finance lease in accordance with ASC 842 as one lease component for the facility, infrastructure and equipment, and the right-of-use asset has been included within property, plant and equipment. Management concluded the lease represents a finance lease on the basis that management believes the lease term covers the remaining economic life of the primary lease component. The initial term of the UHN Agreement will run for five years from the lease commencement date, with an option to renew for additional two-year terms thereafter, subject to certain conditions described in the UHN Agreement. Management included the first option to renew for two years as part of the lease term in determining the right-of-use asset and lease liability. The UHN Agreement does not transfer any title in the Facility to the Company. During the term, the Company shall be responsible for day-to-day management activities and decision-making regarding the Facility. General governance of the Facility will be exercised by the Company and UHN through a joint committee. The joint committee, which will meet quarterly, will have a minimum of six people and will be comprised of an equal number of members from each of the Company and UHN. On March 10, 2023, the Company entered into a lease for an approximately 103,000 square foot facility in Indianapolis (the "Indianapolis Lease"). The lease commencement date was determined to be July 1, 2023, the date upon which the Company was provided access to the facility. The initial term of the lease will run for 121 months from the lease commencement date, with an option to renew for two ten-year terms thereafter, subject to certain conditions described in the Indianapolis Lease. Management did not include either option to renew as part of the lease term in determining the right-of-use asset and lease liability. Management has accounted for the lease as an operating lease as it believes that the lease term does not cover a substantial portion of the economic life of the primary lease component nor does the present value of the minimum lease payments exceed 90% of the fair value of the facility. The lease is recorded on the interim condensed consolidated balance sheet as an operating lease right-of-use asset with a related operating lease liability as of September 30, 2023. The agreement does not transfer any title in the property to the Company. On April 12, 2023, the Company entered into an operating lease for laboratory space with a lease term of two years. The lease commencement date was determined to be April 15, 2023, the date upon which the Company was provided access to the laboratory space. The lease is recorded on the interim condensed consolidated balance sheet as an operating lease right-of-use asset with a related operating lease liability as of September 30, 2023. The agreement does not transfer any title in the laboratory space to the Company. The components of lease expense are as follows: For the nine months ended September 30, 2023 Operating lease expense $ 303,215 Finance lease cost Amortization of right-of-use asset 384,622 Interest on lease liability 196,027 Total finance lease cost $ 580,649 As of September 30, 2022, there were no operating or finance leases recognized in the condensed consolidated financial statements. Supplemental cash flow information related to leases is as follows: For the nine months ended September 30, 2023 Cash flow information: Cash paid for amounts included in the measurement of lease liabilities: Operating cash flow use from operating leases $ 167,397 Operating cash flow use from finance lease $ 196,027 Financing cash flow use from finance lease $ 285,949 Non-cash activity: Right-of-use assets obtained in exchange for lease obligations: Operating leases $ 5,644,563 Finance lease $ 5,384,707 The following table summarizes the weighted average remaining lease terms for the Company’s leases: As of September 30, 2023 Weighted-average remaining lease term (in years): Operating leases 9.2 Finance lease 6.5 Below is information on the weighted average discount rates used at the time that the leases were commenced: As of September 30, 2023 Weighted-average discount rates: Operating leases 7.8 % Finance lease 7.7 % The following table summarizes the future maturities of the Company's lease liabilities as of September 30, 2023: Operating Leases Finance Lease 2023 $ 232,797 $ 246,755 2024 689,632 987,018 2025 797,739 987,018 2026 746,332 987,018 2027 768,722 987,018 Thereafter 4,732,515 2,220,793 Total lease payments $ 7,967,737 $ 6,415,620 Less: imputed interest (2,385,189) (1,335,399) Present value of lease liabilities $ 5,582,548 $ 5,080,221 |
Leases | Leases Right-of-use assets and lease liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. ASC 842 requires a lessee to discount its unpaid lease payments using the interest rate implicit in the lease or, if that rate cannot be readily determined, its incremental borrowing rate. As an implicit interest rate was not readily determinable in the Company’s current portfolio of leases, the incremental borrowing rate was used based on the information available at the commencement date in determining the present value of lease payments. The Company has not incurred any material short-term lease costs or variable lease costs associated with its finance and operating leases. On February 2, 2023, POINT Biopharma Corp., entered into a Facility Agreement (the "UHN Agreement") with University Health Network (“UHN”), a not-for-profit corporation incorporated under the laws of Canada. Pursuant to the UHN Agreement, the Company was provided access to utilize a 7,700 square foot, licensed research and development space with cGMP manufacturing suites (the “Facility”), which the Company will use to develop and expand its pipeline of next-generation radioligands. The lease commencement date was determined to be April 1, 2023, the date upon which the Company was provided access to the Facility. The lease is accounted for as a finance lease in accordance with ASC 842 as one lease component for the facility, infrastructure and equipment, and the right-of-use asset has been included within property, plant and equipment. Management concluded the lease represents a finance lease on the basis that management believes the lease term covers the remaining economic life of the primary lease component. The initial term of the UHN Agreement will run for five years from the lease commencement date, with an option to renew for additional two-year terms thereafter, subject to certain conditions described in the UHN Agreement. Management included the first option to renew for two years as part of the lease term in determining the right-of-use asset and lease liability. The UHN Agreement does not transfer any title in the Facility to the Company. During the term, the Company shall be responsible for day-to-day management activities and decision-making regarding the Facility. General governance of the Facility will be exercised by the Company and UHN through a joint committee. The joint committee, which will meet quarterly, will have a minimum of six people and will be comprised of an equal number of members from each of the Company and UHN. On March 10, 2023, the Company entered into a lease for an approximately 103,000 square foot facility in Indianapolis (the "Indianapolis Lease"). The lease commencement date was determined to be July 1, 2023, the date upon which the Company was provided access to the facility. The initial term of the lease will run for 121 months from the lease commencement date, with an option to renew for two ten-year terms thereafter, subject to certain conditions described in the Indianapolis Lease. Management did not include either option to renew as part of the lease term in determining the right-of-use asset and lease liability. Management has accounted for the lease as an operating lease as it believes that the lease term does not cover a substantial portion of the economic life of the primary lease component nor does the present value of the minimum lease payments exceed 90% of the fair value of the facility. The lease is recorded on the interim condensed consolidated balance sheet as an operating lease right-of-use asset with a related operating lease liability as of September 30, 2023. The agreement does not transfer any title in the property to the Company. On April 12, 2023, the Company entered into an operating lease for laboratory space with a lease term of two years. The lease commencement date was determined to be April 15, 2023, the date upon which the Company was provided access to the laboratory space. The lease is recorded on the interim condensed consolidated balance sheet as an operating lease right-of-use asset with a related operating lease liability as of September 30, 2023. The agreement does not transfer any title in the laboratory space to the Company. The components of lease expense are as follows: For the nine months ended September 30, 2023 Operating lease expense $ 303,215 Finance lease cost Amortization of right-of-use asset 384,622 Interest on lease liability 196,027 Total finance lease cost $ 580,649 As of September 30, 2022, there were no operating or finance leases recognized in the condensed consolidated financial statements. Supplemental cash flow information related to leases is as follows: For the nine months ended September 30, 2023 Cash flow information: Cash paid for amounts included in the measurement of lease liabilities: Operating cash flow use from operating leases $ 167,397 Operating cash flow use from finance lease $ 196,027 Financing cash flow use from finance lease $ 285,949 Non-cash activity: Right-of-use assets obtained in exchange for lease obligations: Operating leases $ 5,644,563 Finance lease $ 5,384,707 The following table summarizes the weighted average remaining lease terms for the Company’s leases: As of September 30, 2023 Weighted-average remaining lease term (in years): Operating leases 9.2 Finance lease 6.5 Below is information on the weighted average discount rates used at the time that the leases were commenced: As of September 30, 2023 Weighted-average discount rates: Operating leases 7.8 % Finance lease 7.7 % The following table summarizes the future maturities of the Company's lease liabilities as of September 30, 2023: Operating Leases Finance Lease 2023 $ 232,797 $ 246,755 2024 689,632 987,018 2025 797,739 987,018 2026 746,332 987,018 2027 768,722 987,018 Thereafter 4,732,515 2,220,793 Total lease payments $ 7,967,737 $ 6,415,620 Less: imputed interest (2,385,189) (1,335,399) Present value of lease liabilities $ 5,582,548 $ 5,080,221 |
Stockholders' equity
Stockholders' equity | 9 Months Ended |
Sep. 30, 2023 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' equity | Stockholders’ equity The Company is authorized to issue 430,000,000 shares of common stock, with a par value of $0.0001 per share ("Common Stock"), as well as 20,000,000 of shares of preferred stock, with a par value of $0.0001 per share (“Preferred Stock”). During the three months ended September 30, 2023, there were no issuances of Common Stock. During the nine months ended September 30, 2023, the Company issued (i) 86,585 shares of Common Stock in connection with the exercise of stock options granted to non-employee consultants, resulting in total cash proceeds of $120,353 and (ii) 29,628 shares of Common Stock in connection with the exercise of stock options granted to employees and directors, resulting in total cash proceeds of $211,569. During the three months ended September 30, 2022, the Company issued (a) 13,900,000 shares of Common Stock in connection with an underwritten public share offering at the price of $9.00 per share pursuant to a registration statement on Form S-3 previously filed and declared effective by the Securities and Exchange Commission, resulting in total gross proceeds of $125.1 million (excluding approximately $8.2 million of issuance costs) and (b) 30,000 shares of Common Stock in connection with the exercise of stock options issued to a non-employee consultant, resulting in total cash proceeds of $41,700. During the nine months ended September 30, 2022, the Company issued 13,933,168 shares of Common Stock, including the 13,930,000 shares of Common Stock discussed above, as well as 3,168 shares of Common Stock in connection with the exercise of stock options issued to non-employee consultants, resulting in total cash proceeds of $4,403. As of September 30, 2023, the total number of issued and outstanding shares of Common Stock was 105,765,954 (December 31, 2022 — 105,649,741). As of September 30, 2023, there were no issued and outstanding shares of Preferred Stock (December 31, 2022 — $nil). Each share of Common Stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders. Holders of Common Stock are entitled to receive dividends, if any, as may be declared by the Company’s board of directors (the “Board”). During the three and nine months ended September 30, 2023, no cash dividends were declared or paid by the Company (September 30, 2022 — $nil). The Board has the authority to issue shares of Preferred Stock from time to time on terms it may determine, to divide shares of Preferred Stock into one or more series and to fix the designations, preferences, privileges, and restrictions of Preferred Stock, including dividend rights, conversion rights, voting rights, terms of redemption, liquidation preference, sinking fund terms, and the number of shares constituting any series or the designation of any series to the fullest extent permitted by the Delaware General Corporation Law ("DGCL"). During the nine months ended September 30, 2023, no shares of Preferred Stock were issued by the Company. |
Stock-based compensation
Stock-based compensation | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-based compensation | Stock-based compensationIn March 2020, the board of directors of POINT Biopharma Inc. approved the 2020 Equity Incentive Plan (the “2020 EIP”). The 2020 EIP provided for the granting of incentive and non-qualified stock options, stock appreciation rights, restricted stock units, performance awards and other stock-based awards to employees, directors, and consultants of POINT Biopharma Inc. Effective as of June 30, 2021, the Board adopted the POINT Biopharma Global Inc. 2021 Equity Incentive Plan (the “2021 EIP”) to replace the 2020 EIP and allow the Company to grant equity and equity-based incentive awards to officers, employees, non-employee directors and consultants of the Company. The Company assumed the outstanding equity awards under the 2020 EIP, but no further grants may be made under the 2020 EIP. The 2021 EIP provides that the number of shares reserved and available for issuance under the 2021 EIP will automatically increase each January 1, beginning on January 1, 2022, by 4% of the number of outstanding shares of Common Stock on the immediately preceding December 31, or such lesser amount as determined by the Board. As of January 1, 2023, the number of shares of Common Stock available under the 2021 EIP increased by 4,225,990 for a total of 9,049,548 shares of Common Stock authorized for issuance under the 2021 EIP as of September 30, 2023. Stock options The Company recorded $666,368 and $1,797,759 to research and development expenses and $1,210,064 and $2,798,518 to general and administrative expenses for stock-based compensation for the three and nine months ended September 30, 2023, respectively (September 30, 2022 — $476,481 and $1,220,426 to research and development expenses and $602,575 and $1,326,643 to general and administrative expenses for the three and nine months ended, respectively). The Company did not recognize a tax benefit related to stock-based compensation expense during the three and nine months ended September 30, 2023 as well as during the three and nine months ended September 30, 2022, as the Company had net operating loss carryforwards and recorded a valuation allowance against the deferred tax asset. The following table summarizes the activity relating to the Company’s stock options. Number of Weighted Weighted- Outstanding as of December 31, 2022 5,592,173 5.85 Granted 3,294,071 7.09 Exercised (116,213) 2.86 Forfeited (176,942) 7.23 Expired (15,510) 8.29 Outstanding as of September 30, 2023 8,577,579 6.33 4.4 Vested and expected to vest as of September 30, 2023 8,577,579 6.33 4.4 Options exercisable as of September 30, 2023 2,985,114 5.19 3.7 During the three months ended September 30, 2023, 150,000 stock options were granted to an employee of the Company, with a weighted average grant date fair value of $4.57 per share. During the nine months ended September 30, 2023, 3,294,071 stock options were granted, including the 150,000 stock options discussed above as well as 3,144,071 stock options granted to employees and directors of the Company, with a weighted average grant date fair value of $3.85 per share. The vesting terms of the options granted to employees of the Company are such that 25% of the options vest on the one-year anniversary of the date of grant and the remaining 75% of such stock options vest in three During the three months ended September 30, 2022, there were no stock options granted. During the nine months ended September 30, 2022, 1,948,614 stock options were granted to employees and directors of the Company, with a weighted average grant date fair value of $4.59 per share. Except as provided below with respect to options granted to directors, the vesting terms of these options are such that 25% of the options vest on the one-year anniversary of the date of grant and the remaining 75% of such stock options vest in three The following table presents the assumptions used in the Black-Scholes-Merton option-pricing model to determine the grant date fair value of stock options granted: Three months ended September 30, 2023 Three months ended September 30, 2022 Nine months ended September 30, 2023 Nine months ended September 30, 2022 Risk-free interest rate 4.47% — 3.71% - 4.47% 1.24% - 3.13% Expected term (in years) 4.25 — 3.50 - 4.25 4.25 Expected volatility 66% —% 66% - 68% 72% - 75% Expected dividend yield —% —% —% —% During the three months ended September 30, 2023, there were no stock option exercises. During the nine months ended September 30, 2023, non-employee consultants of the Company exercised 86,585 stock options with an intrinsic value of $700,217, and employees and directors of the Company exercised 29,628 stock options with an intrinsic value of $38,300, for total cash proceeds to the Company of $331,922. During the three and nine months ended September 30, 2022, non-employee consultants of the Company exercised 30,000 and 33,168 stock options with intrinsic values of $238,300 and $257,601, respectively. The exercises resulted in cash proceeds to the Company of $41,700 and $46,103, respectively. As of September 30, 2023, the unrecognized stock-based compensation expense related to unvested stock options was $17,944,644 and the estimated weighted average remaining vesting period was 2.9 years. Performance Share Units During the year ended December 31, 2022, 146,044 performance share units ("PSUs") were granted to employees of the Company, with a grant date fair value of $6.61 per unit based on the closing share price of the Company's Common Stock on the date of grant. The vesting terms of these PSUs are such that 100% vest upon the regulatory approval of PNT2002 by the FDA. During the three and nine months ended September 30, 2023, the Company did not record any stock-based compensation expense related to these PSUs on the basis that they cannot be considered probable to vest as the regulatory approval requirement is outside the control of the Company and the clinical trial remains ongoing. |
Commitments and contingencies
Commitments and contingencies | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and contingencies | Commitments and contingencies Indianapolis facility commitments The Company is party to certain agreements for the continuing expansion of the manufacturing capabilities of the Indianapolis facility (see Note 7). Effective in the second quarter of 2022, the Company entered into an agreement for the design and build of a commercial manufacturing line. As of September 30, 2023, the Company is committed to aggregate future payments of approximately $22.5 million in connection with these agreements. During the three and nine months ended September 30, 2023, approximately $5.2 million and $15.5 million, respectively, has been recorded within property, plant and equipment in connection with these agreements (three and nine months ended September 30, 2022 — approximately $3.7 million and $7.7 million, respectively). Clinical trial and commercial commitments The Company, in the normal course of business, enters into various services and supply agreements in connection with its clinical trials to ensure the supply of certain products and product lines during the Company’s clinical phase. These agreements often have minimum purchase commitments and generally terminate upon the termination of the clinical trial. As at September 30, 2023, aggregate remaining minimum commitments amount to approximately $5.4 million with payments ranging from three The Company also has supply agreements with third parties to purchase certain products for use in the Company’s full scale production process. The Company is committed to purchase a minimum quantity of products in the amount of approximately $109.2 million ($148.3 million CAD) with payments ranging from two On May 10, 2023, the Company entered into an Irradiation Services Agreement (the "Irradiation Agreement") which expands the Company's reactor network. Pursuant to the Irradiation Agreement, the Company will receive irradiation services to irradiate ytterbium-176 (“ 176 Yb”) and has minimum purchase commitments of approximately $32.4 million over the ten-year contract term. During the three and nine months ended September 30, 2023, the Company did not record any research and development expenses in connection with this agreement. On September 25, 2023, the Company entered into a Supply Agreement (the "Supply Agreement") for the supply of carrier-free lutetium-177 (n.c.a. 177 Lu). The Supply Agreement has a term of ten years and has minimum purchase commitments of approximately $107.4 million (€101.8 million) subject to certain conditions in the Supply Agreement, including the successful validation of the supplier-produced 177 Lu with the intended compounds. The Company recorded research and development expenses in connection with this agreement of approximately $0.2 million and $0.2 million during the three and nine months ended September 30, 2023, respectively. The Company also has an agreement with a third party to provide certain services in connection with the Company’s SPLASH clinical phase study. The agreement expires on the date of the completion or termination of the clinical trial. As of September 30, 2023, the remaining minimum purchase commitment under this agreement is approximately $23.7 million with payments that range from one License agreements The Company, in the normal course of business, enters into license and sublicense agreements in connection with its clinical trials and product development. For additional details about the Company’s license agreements, see Note 15 to the 2022 Financial Statements. On April 17, 2023, POINT Biopharma Inc. entered into first and second amendments (the "Amendments") to that certain Sublicense Agreement, dated November 14, 2019, between POINT Biopharma Inc. and Scintomics GmbH ("Scintomics"). Pursuant to the Amendments, the exclusive, sublicensable, license was expanded to include all geographies worldwide and the Company has increased flexibility in connection with sublicense arrangements. On September 11, 2023, POINT Biopharma Inc. entered into a collaboration and license agreement between POINT Biopharma Inc. and Athebio AG ("Athebio") (the "Athebio Agreement"). Pursuant to the Agreement, the Company is granted exclusive access to Athebio's intellectual property and capabilities in the designed ankyrin repeat proteins ("DARPins") development. The Company recorded research and development expenses in connection with this agreement of $1.0 million during the three and nine months ended September 30, 2023. In addition, in connection with the Athebio agreement, the Company is committed to enter into a stock purchase agreement by which the Company will invest a total of $5.0 million subject to certain conditions and milestones set forth in the Athebio Agreement. The Company recorded aggregate research and development expenses in connection with its license agreements of approximately $1.5 million and $5.0 million during the three and nine months ended September 30, 2023, respectively (three and nine months ended September 30, 2022 — $0.8 million and $5.3 million, respectively). |
Net loss per share
Net loss per share | 9 Months Ended |
Sep. 30, 2023 | |
Earnings Per Share [Abstract] | |
Net loss per share | Net loss per share Basic loss per share is computed by dividing the loss available to common stockholders by the weighted-average number of shares of Common Stock outstanding during the period. Diluted loss per share is computed by dividing loss available to common stockholders by the weighted-average number of shares of Common Stock outstanding during the period increased to include the number of additional shares of Common Stock that would have been outstanding if the potentially dilutive securities had been issued, using the treasury stock method. Three months ended September 30, 2023 Three months ended September 30, 2022 Nine months ended September 30, 2023 Nine months ended September 30, 2022 Net loss $ 24,774,353 $ 24,013,069 $ 66,715,863 $ 64,973,890 Weighted-average common shares outstanding-basic and diluted 105,765,954 92,401,484 105,717,330 90,891,031 Net loss per share-basic and diluted $ 0.23 $ 0.26 $ 0.63 $ 0.71 The Company’s potentially dilutive securities, which include stock options, have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. The Company's PSU's are considered contingently issuable shares for the purpose of the computation of loss per share and have been excluded on the basis that |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The Company calculates its interim tax provision at the end of each interim period and estimates the annual effective tax rate, which is applied to its ordinary quarterly earnings. The computation of the annual estimated effective tax rate at each interim period requires certain estimates and significant judgment including, but not limited to, the expected operating income for the year, projections of the proportion of income earned and taxed in foreign jurisdictions, permanent and temporary differences between book and tax amounts, and the likelihood of recovering deferred tax assets generated in the current year. The accounting estimates used to compute the provision for income taxes may change as new events occur, additional information is obtained or as the tax environment changes. The Company has operations in both the United States and Canada, and as such it is subject to tax in both countries. The income tax expense for the three months ended September 30, 2023 and September 30, 2022 was $871,449 and $180,500, respectively and the income tax benefit and expense for the nine months ended September 30, 2023 and September 30, 2022 was $288,491 and $452,021, respectively. The income tax amounts for the three and nine months ended September 30, 2023, include tax benefits related to research and development tax credits partially offset by current federal, state, and Canadian income tax adjustments. The three months ended September 30, 2023 also includes prior year current income tax adjustments in the United States jurisdictions. The income tax expense for the three and nine months ended September 30, 2022, consists of current taxes in Canada. The Company files income tax returns in the U.S. federal, certain states, and Canada with varying statutes of limitations. The Company is not currently subject to tax examinations by any taxing jurisdiction. However, in the event of any such examination, there may or may not be an impact on the Company’s net operating loss carryforwards and credits. The Company does not anticipate that any potential tax adjustments resulting from such examinations would have a significant impact on its financial position or results of operations. As of September 30, 2023, the Company believes no significant changes in the unrecognized tax benefits will occur within the next 12 months. |
Related party transactions
Related party transactions | 9 Months Ended |
Sep. 30, 2023 | |
Related Party Transactions [Abstract] | |
Related party transactions | Related party transactions The Company recognized expenses in connection with related party transactions in the unaudited interim condensed consolidated statements of operations as follows: Three months ended September 30, 2023 Three months ended September 30, 2022 Nine months ended September 30, 2023 Nine months ended September 30, 2022 Consulting fees on business activities to Board member $ 90,161 $ 90,040 $ 296,072 $ 259,132 Reimbursement to Board member for occupancy costs 18,219 17,395 53,532 53,071 Total $ 108,380 $ 107,435 $ 349,604 $ 312,203 Transactions with related parties are in the normal course of operations and have been measured at their agreed upon exchange amount. During the three and nine-month periods ended September 30, 2023 and 2022, the Company received consulting services for research and development from a Board member. As of September 30, 2023, $43,859 is recorded within accrued liabilities in relation to this consulting arrangement. The Company currently has a lease arrangement in place with a Board member for the use of office space. The arrangement does not have a defined contractual lease term and is payable monthly. The Company has applied the short-term lease exemption under ASC 842 to this arrangement and is recording the lease payments of approximately $6,000 monthly as rent expense. |
Subsequent events
Subsequent events | 9 Months Ended |
Sep. 30, 2023 | |
Subsequent Events [Abstract] | |
Subsequent events | Subsequent eventsIonetix Amendment of Convertible Note Purchase Agreement On September 29, 2023, POINT Biopharma Inc. entered into the Amendment, whereby on October 2, 2023 the Company purchased an additional $5.0 million of unsecured promissory notes from Ionetix-α. In connection with the Convertible Note Agreement, this additional purchase was originally scheduled for six months from the initial purchase date of June 1, 2023. See Note 5. Merger Agreement As previously announced, on October 2, 2023, Eli Lilly and Company, an Indiana corporation (“Parent”), Yosemite Falls Acquisition Corporation, a Delaware corporation and a wholly owned subsidiary of Parent (“Merger Sub”), and the Company entered into an Agreement and Plan of Merger (the “Merger Agreement”). Merger Sub commenced the cash tender offer (the “Offer”) to purchase all of the outstanding shares of Common Stock (the “Shares”), at a price of $12.50 per share, net to the stockholder in cash, without interest and less any applicable withholding taxes, upon the terms and subject to the conditions set forth in the Merger Agreement. The Offer commenced on October 13, 2023 and was initially scheduled to expire at one minute after 11:59 p.m., Eastern time, on November 9, 2023. On November 8, 2023, Parent extended the expiration of the Offer until 5:00 p.m., Eastern Time, on November 16, 2023, unless further extended or earlier terminated in accordance with the terms of the Offer and the Merger Agreement and the applicable rules and regulations of the SEC. Consummation of the Offer is subject to the satisfaction or waiver of various conditions set forth in the Merger Agreement, including (a) there shall have been validly tendered in the Offer (and not properly withdrawn) prior to the expiration of the Offer that number of Shares (excluding Shares tendered pursuant to guaranteed delivery procedures that have not yet been “received” by the “depository,” as such terms are defined by Section 251(h) of the DGCL) that, when added to the Shares then owned by Parent, Merger Sub or any subsidiary of Parent, would represent at least a majority of the Shares outstanding as of immediately following the consummation of the Offer, (b) the expiration or termination of the waiting period under the HSR Act, (c) the accuracy of the Company’s representations and warranties contained in the Merger Agreement (except, generally, for any inaccuracies that have not had a Company Material Adverse Effect (as defined in the Merger Agreement)), (d) the Company’s performance in all material respects of its obligations under the Merger Agreement, (e) consent by the U.S. Nuclear Regulatory Commission of the indirect transfer of control with respect to the Company and (f) the other conditions set forth in Exhibit A to the Merger Agreement. On October 23, 2023, Parent and the Company filed their respective Premerger Notification and Report Forms pursuant to the HSR Act with the U.S. Federal Trade Commission (the “FTC”) and the Antitrust Division of the U.S. Department of Justice (the “Antitrust Division”), initiating a 15-day waiting period. The 15-day waiting period under the HSR Act expired on November 7, 2023 at 11:59 p.m., Eastern Time. Accordingly, the condition to the Offer relating to the expiration or termination of the waiting period under the HSR Act has been satisfied. The Company could be required to pay the Parent a termination fee of approximately $54.4 million if the Merger Agreement is terminated under specific circumstances described in the Merger Agreement. The consummation of the Offer and the Merger is not subject to a financing condition. For more information on the Offer and the Merger, refer to the Company's Current Report on Form 8-K filed October 3, 2023. |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) | 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 | |
Pay vs Performance Disclosure | ||||||||
Net loss | $ (24,774,353) | $ (25,410,839) | $ (16,530,671) | $ (24,013,069) | $ (24,580,247) | $ (16,380,574) | $ (66,715,863) | $ (64,973,890) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Sep. 30, 2023 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Summary of significant accoun_2
Summary of significant accounting policies (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Basis of presentation | Basis of presentation The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 270, Interim Reporting and include the accounts of the Company and the Subsidiaries, for financial information and pursuant to the rules and regulations of the Securities and Exchange Commission ("SEC"). Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the United States of America (“GAAP”). All intercompany accounts and transactions have been eliminated in consolidation. In the opinion of management, the unaudited interim condensed consolidated 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. Except as described below, the accounting policies and methods of computation applied in the unaudited interim condensed consolidated financial statements and related notes contained therein are consistent with those applied by the Company in its audited consolidated financial statements as of and for the year ended December 31, 2022 contained in our Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the SEC on March 27, 2023 (the “2022 Financial Statements”). These unaudited interim condensed consolidated financial statements should be read in conjunction with the 2022 Financial Statements. |
Going concern | These unaudited interim condensed consolidated financial statements and accompanying notes have been prepared in accordance with the provisions of ASC Topic 205-40, Presentation of Financial Statements—Going Concern on the basis that the Company will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. |
Risks and uncertainties | Risks and uncertainties Except for the upfront payment received pursuant to the Lantheus License Agreements (as defined in Note 3 below), the Company has incurred significant net losses and has funded operations primarily through equity financings. Operating losses and negative cash flows were incurred in the nine months ended September 30, 2023 and are expected to continue to be incurred in future periods. The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, successful discovery and development of its product candidates, regulatory approval of its product candidates, development by competitors of new technological innovations, dependence on key personnel, the ability to attract and retain qualified employees, protection of proprietary technology, compliance with governmental regulations, the impact of macroeconomic disruptions, such as those arising from public health crisis or military conflicts and adverse developments affecting the financial services industry, the ability to secure additional capital to fund operations and commercial success of its product candidates. Product candidates currently under development will require extensive preclinical and clinical testing and regulatory approval prior to commercialization. These efforts require significant amounts of capital, adequate personnel, and infrastructure and extensive compliance-reporting capabilities. Even if the Company’s drug development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales. The Company also has a number of risks and uncertainties related to the Offer and Merger described in Note 16. These risks and uncertainties are described in more detail in Part II. Item 1A. “Risk Factors” starting on page 34. |
Use of estimates | Use of estimates The preparation of the unaudited interim condensed consolidated financial statements in conformity with GAAP requires management to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, related disclosure of contingent assets and liabilities at the date of the unaudited interim condensed consolidated financial statements, and the reported amounts of expenses for the periods presented. Significant estimates and assumptions reflected in these unaudited interim condensed consolidated financial statements include, but are not limited to, the allocation of consideration and the recognition of revenues in respect of the performance obligations under the Lantheus License Agreements, the accrual of research and development expenses, incremental borrowing rates determined in connection with finance and operating lease obligations, the valuations of stock options, the expected recoverability of and the estimated useful lives of our long-lived assets. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances. On an ongoing basis, management evaluates its estimates when there are changes in circumstances, facts and experiences. Changes in estimates are recorded in the period in which they become known. Actual results may differ from those estimates or assumptions. |
Leases | Leases The Company accounts for leases in accordance with ASC Topic 842, Leases ("ASC 842"). At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present. The Company has elected not to recognize leases with an original term of one year or less in the consolidated balance sheets. The Company has also elected to account for the lease and non-lease components as a combined lease component for its current lease portfolio. Right-of-use assets and lease liabilities are recognized at the commencement date based on the present value of lease payments over the lease term. Options to renew or early terminate a lease are included in the initial lease term of a lease when there is reasonable certainty that the option will be applied. ASC 842 requires a lessee to discount its unpaid lease payments using the interest rate implicit in the lease or, if that rate cannot be readily determined, its incremental borrowing rate. The Company's incremental borrowing rate is determined using a secured borrowing rate for the same currency and term as the associated lease in a similar economic environment. Lease expense for operating leases is recognized on a straight-line basis over the lease term and included in operating expenses in the condensed consolidated statements of operations and comprehensive loss. |
Recent accounting pronouncements | Recent accounting pronouncements The Company has evaluated accounting pronouncements recently issued but not yet adopted and believes that the accounting pronouncements currently do not apply to the Company’s operations and are not expected to have a material impact on the Company’s unaudited interim condensed consolidated financial statements or disclosures. |
Revenue (Tables)
Revenue (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Revenue from Contract with Customer [Abstract] | |
Schedule of Contract Liabilities | The following table presents the Company’s contract liabilities as of September 30, 2023 and December 31, 2022 : September 30, 2023 December 31, 2022 Deferred revenue Deferred revenue, current $ 12,586,443 $ 23,242,290 Deferred revenue, net of current portion 3,720,881 10,178,147 Total $ 16,307,324 $ 33,420,437 |
Cash, cash equivalents and in_2
Cash, cash equivalents and investments (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Cash and Cash Equivalents [Abstract] | |
Schedule of Cash, Cash Equivalents and Investments | Cash, cash equivalents and investments consisted of the following: As of September 30, 2023 As of December 31, 2022 Cash $ 11,446,728 $ 12,429,627 Cash equivalents: Money market funds 6,852,616 273,998,744 Commercial paper 3,308,068 — Total cash and cash equivalents 21,607,412 286,428,371 Short-term investments Commercial paper 107,567,350 115,156,455 Corporate bonds 93,787,733 45,219,042 U.S. Government agency debt securities 35,942,645 42,577,762 Asset backed securities 80,258,208 35,830,211 Total short-term investments 317,555,936 238,783,470 Long-term investments U.S. Government agency debt securities 16,098,662 — Asset backed securities 8,634,828 16,119,430 Corporate bonds 35,059,671 — Total long-term investments 59,793,161 16,119,430 Total cash, cash equivalents and investments $ 398,956,509 $ 541,331,271 |
Schedule of Available-For-Sale Investments | The amortized cost, gross unrealized gains, gross unrealized losses and fair value of available-for-sale investments by type of security as of September 30, 2023 were as follows: Amortized Cost Unrealized Gains Unrealized Losses Fair Value Current Non-current Commercial paper $ 107,597,155 $ 981 $ (30,786) $ 107,567,350 $ 107,567,350 $ — Corporate bonds 129,438,450 5,918 (596,964) 128,847,404 93,787,733 35,059,671 Asset backed securities 89,554,665 204 (661,833) 88,893,036 80,258,208 8,634,828 U.S. Government agency debt securities 52,186,023 — (144,716) 52,041,307 35,942,645 16,098,662 Total available-for-sale securities $ 378,776,293 $ 7,103 $ (1,434,299) $ 377,349,097 $ 317,555,936 $ 59,793,161 The amortized cost, gross unrealized gains, gross unrealized losses and fair value of available-for-sale investments by type of security as of December 31, 2022 were as follows: Amortized Cost Unrealized Gains Unrealized Losses Fair Value Current Non-current Commercial paper $ 115,156,455 $ — $ — $ 115,156,455 $ 115,156,455 $ — Asset backed securities 52,019,619 26,527 (96,505) 51,949,641 35,830,211 16,119,430 Corporate bonds 45,468,482 — (249,440) 45,219,042 45,219,042 — U.S. Government agency debt securities 42,715,195 — (137,433) 42,577,762 42,577,762 — Total available-for-sale securities $ 255,359,751 $ 26,527 $ (483,378) $ 254,902,900 $ 238,783,470 $ 16,119,430 The following table summarizes the fair value of available-for-sale investments based on stated contractual maturities as of September 30, 2023: Amortized Cost Fair Value Due within one year $ 318,607,866 $ 317,555,936 Due between one and five years 60,168,427 59,793,161 Total $ 378,776,293 $ 377,349,097 The following table summarizes the fair value of available-for-sale investments based on stated contractual maturities as of December 31, 2022: Amortized Cost Fair Value Maturing within one year $ 239,236,498 $ 238,783,470 Maturing between one and five years 16,123,253 16,119,430 Total $ 255,359,751 $ 254,902,900 |
Fair value measurements (Tables
Fair value measurements (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Schedule of Financial Assets and Liabilities Measured at Fair Value | The following tables present information about the Company’s financial assets and liabilities as of September 30, 2023 and December 31, 2022, that are measured at fair value on a recurring basis and indicates the level of the fair value hierarchy used to determine such fair values: Level 1 Level 2 Level 3 Total September 30, 2023 Cash equivalents: Money market mutual fund $ 6,852,616 $ — $ — $ 6,852,616 Commercial paper — 3,308,068 — 3,308,068 Available-for-sale debt securities: Commercial paper — 107,567,350 — 107,567,350 Corporate bonds — 128,847,404 — 128,847,404 Asset backed securities — 88,893,036 — 88,893,036 U.S. Government agency debt securities 52,041,307 — — 52,041,307 Total $ 58,893,923 $ 328,615,858 $ — $ 387,509,781 Level 1 Level 2 Level 3 Total December 31, 2022 Cash equivalents: Money market mutual fund $ 273,998,744 $ — $ — $ 273,998,744 Commercial paper — — — — Available-for-sale debt securities: Commercial paper — 115,156,455 — 115,156,455 Asset backed securities — 51,949,641 — 51,949,641 Corporate bonds — 45,219,042 — 45,219,042 U.S. Government agency debt securities 42,577,762 — — 42,577,762 Total $ 316,576,506 $ 212,325,138 $ — $ 528,901,644 |
Prepaid expenses and other cu_2
Prepaid expenses and other current assets (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Prepaid Expense and Other Assets, Current [Abstract] | |
Summary of Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets consisted of the following: As of September 30, 2023 As of December 31, 2022 $ $ Prepaid clinical trial expenses 2,812,270 4,011,419 Prepaid insurance 1,390,347 1,310,314 Receivable on matured short-term investment 5,000,000 — Canadian harmonized sales tax receivable 206,326 60,222 Deposit on production equipment — 13,738 Other 492,786 215,196 Total 9,901,729 5,610,889 |
Property, plant and equipment_2
Property, plant and equipment, net (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Property, Plant and Equipment [Abstract] | |
Summary of Property, Plant and Equipment, Net | Property, plant and equipment, net consisted of the following: As of September 30, 2023 As of December 31, 2022 $ $ Land and building 19,992,990 18,163,962 Machinery and equipment 11,241,336 5,328,639 Property, plant and equipment, in development 19,827,730 8,434,384 Facility lease (Note 9) 5,384,707 — Furniture and fixtures 938,909 698,728 Computer equipment 237,963 149,892 57,623,635 32,775,605 Less: Accumulated depreciation (3,581,282) (1,395,029) Total 54,042,353 31,380,576 Asset Category Estimated Useful Life Computer equipment 5 years Machinery and equipment 7 years Furniture and fixtures 7 years Facility lease 7 years Building 20 years |
Accrued liabilities (Tables)
Accrued liabilities (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Accrued Liabilities, Current [Abstract] | |
Summary of Accrued Liabilities | Accrued liabilities consisted of the following: As of September 30, 2023 As of December 31, 2022 $ $ Accrued personnel costs 5,663,218 7,116,382 Accrued research and development costs 7,766,189 9,645,594 Accrued corporate legal fees and other professional services 907,019 2,068,793 Accrued costs for purchases of property, plant and equipment 75,360 105,741 Other accrued costs 117,568 157,944 Total 14,529,354 19,094,454 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Leases [Abstract] | |
Schedule of Lease Expense and Supplemental Cash Flow | The components of lease expense are as follows: For the nine months ended September 30, 2023 Operating lease expense $ 303,215 Finance lease cost Amortization of right-of-use asset 384,622 Interest on lease liability 196,027 Total finance lease cost $ 580,649 As of September 30, 2022, there were no operating or finance leases recognized in the condensed consolidated financial statements. Supplemental cash flow information related to leases is as follows: For the nine months ended September 30, 2023 Cash flow information: Cash paid for amounts included in the measurement of lease liabilities: Operating cash flow use from operating leases $ 167,397 Operating cash flow use from finance lease $ 196,027 Financing cash flow use from finance lease $ 285,949 Non-cash activity: Right-of-use assets obtained in exchange for lease obligations: Operating leases $ 5,644,563 Finance lease $ 5,384,707 The following table summarizes the weighted average remaining lease terms for the Company’s leases: As of September 30, 2023 Weighted-average remaining lease term (in years): Operating leases 9.2 Finance lease 6.5 Below is information on the weighted average discount rates used at the time that the leases were commenced: As of September 30, 2023 Weighted-average discount rates: Operating leases 7.8 % Finance lease 7.7 % |
Operating Lease Maturity | The following table summarizes the future maturities of the Company's lease liabilities as of September 30, 2023: Operating Leases Finance Lease 2023 $ 232,797 $ 246,755 2024 689,632 987,018 2025 797,739 987,018 2026 746,332 987,018 2027 768,722 987,018 Thereafter 4,732,515 2,220,793 Total lease payments $ 7,967,737 $ 6,415,620 Less: imputed interest (2,385,189) (1,335,399) Present value of lease liabilities $ 5,582,548 $ 5,080,221 |
Stock-based compensation (Table
Stock-based compensation (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Summary of Stock Option Activity | The following table summarizes the activity relating to the Company’s stock options. Number of Weighted Weighted- Outstanding as of December 31, 2022 5,592,173 5.85 Granted 3,294,071 7.09 Exercised (116,213) 2.86 Forfeited (176,942) 7.23 Expired (15,510) 8.29 Outstanding as of September 30, 2023 8,577,579 6.33 4.4 Vested and expected to vest as of September 30, 2023 8,577,579 6.33 4.4 Options exercisable as of September 30, 2023 2,985,114 5.19 3.7 |
Summary of Assumptions Used to Determine the Grant Date Fair Value of Stock Options Granted | The following table presents the assumptions used in the Black-Scholes-Merton option-pricing model to determine the grant date fair value of stock options granted: Three months ended September 30, 2023 Three months ended September 30, 2022 Nine months ended September 30, 2023 Nine months ended September 30, 2022 Risk-free interest rate 4.47% — 3.71% - 4.47% 1.24% - 3.13% Expected term (in years) 4.25 — 3.50 - 4.25 4.25 Expected volatility 66% —% 66% - 68% 72% - 75% Expected dividend yield —% —% —% —% |
Net loss per share (Tables)
Net loss per share (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Earnings Per Share [Abstract] | |
Summary of Basic and Diluted Net Loss per Share | Three months ended September 30, 2023 Three months ended September 30, 2022 Nine months ended September 30, 2023 Nine months ended September 30, 2022 Net loss $ 24,774,353 $ 24,013,069 $ 66,715,863 $ 64,973,890 Weighted-average common shares outstanding-basic and diluted 105,765,954 92,401,484 105,717,330 90,891,031 Net loss per share-basic and diluted $ 0.23 $ 0.26 $ 0.63 $ 0.71 |
Related party transaction (Tabl
Related party transaction (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Related Party Transactions [Abstract] | |
Schedule of Related Party Transactions | The Company recognized expenses in connection with related party transactions in the unaudited interim condensed consolidated statements of operations as follows: Three months ended September 30, 2023 Three months ended September 30, 2022 Nine months ended September 30, 2023 Nine months ended September 30, 2022 Consulting fees on business activities to Board member $ 90,161 $ 90,040 $ 296,072 $ 259,132 Reimbursement to Board member for occupancy costs 18,219 17,395 53,532 53,071 Total $ 108,380 $ 107,435 $ 349,604 $ 312,203 |
Nature of business - Narrative
Nature of business - Narrative (Details) | 9 Months Ended |
Sep. 30, 2023 subsidiary | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Number of wholly-owned subsidiaries | 4 |
Revenue - Narrative (Details)
Revenue - Narrative (Details) - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||
Dec. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Revenue Recognition, Milestone Method [Line Items] | |||||
Revenue recognized for future performance | $ 34.8 | ||||
Revenue recognized | $ 2.8 | $ 0 | $ 17.1 | $ 0 | |
Lantheus Holdings, Inc. | License Agreements, PNT2002 Agreement | |||||
Revenue Recognition, Milestone Method [Line Items] | |||||
Upfront payment | 250 | ||||
Milestone payment | $ 250 | ||||
Royalty rate | 20% | ||||
Annual net sales milestone payment | $ 1,300 | ||||
Lantheus Holdings, Inc. | License Agreements, PNT2003 Agreement | |||||
Revenue Recognition, Milestone Method [Line Items] | |||||
Upfront payment | 10 | ||||
Milestone payment | $ 30 | ||||
Royalty rate | 15% | ||||
Annual net sales milestone payment | $ 275 |
Revenue - Contract Liabilities
Revenue - Contract Liabilities (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Revenue from Contract with Customer [Abstract] | ||
Deferred revenue, current | $ 12,586,443 | $ 23,242,290 |
Deferred revenue, net of current portion | 3,720,881 | 10,178,147 |
Total | $ 16,307,324 | $ 33,420,437 |
Cash, cash equivalents and in_3
Cash, cash equivalents and investments - Schedule of cash, cash equivalents, and investments (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Cash and Cash Equivalents [Line Items] | ||
Cash | $ 11,446,728 | $ 12,429,627 |
Money market funds | 6,852,616 | 273,998,744 |
Commercial paper | 3,308,068 | 0 |
Total cash and cash equivalents | 21,607,412 | 286,428,371 |
Short-term investments | 317,555,936 | 238,783,470 |
Long-term investments | 59,793,161 | 16,119,430 |
Total cash, cash equivalents and investments | 398,956,509 | 541,331,271 |
Commercial paper | ||
Cash and Cash Equivalents [Line Items] | ||
Short-term investments | 107,567,350 | 115,156,455 |
Corporate bonds | ||
Cash and Cash Equivalents [Line Items] | ||
Short-term investments | 93,787,733 | 45,219,042 |
Long-term investments | 35,059,671 | 0 |
U.S. Government agency debt securities | ||
Cash and Cash Equivalents [Line Items] | ||
Short-term investments | 35,942,645 | 42,577,762 |
Long-term investments | 16,098,662 | 0 |
Asset backed securities | ||
Cash and Cash Equivalents [Line Items] | ||
Short-term investments | 80,258,208 | 35,830,211 |
Long-term investments | $ 8,634,828 | $ 16,119,430 |
Cash, cash equivalents and in_4
Cash, cash equivalents and investments - Schedule of available-for-sale investments (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | $ 378,776,293 | $ 255,359,751 |
Unrealized Gains | 7,103 | 26,527 |
Unrealized Losses | (1,434,299) | (483,378) |
Fair Value | 377,349,097 | 254,902,900 |
Current | 317,555,936 | 238,783,470 |
Non-current | 59,793,161 | 16,119,430 |
Commercial paper | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 107,597,155 | 115,156,455 |
Unrealized Gains | 981 | 0 |
Unrealized Losses | (30,786) | 0 |
Fair Value | 107,567,350 | 115,156,455 |
Current | 107,567,350 | 115,156,455 |
Non-current | 0 | 0 |
Corporate bonds | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 129,438,450 | 52,019,619 |
Unrealized Gains | 5,918 | 26,527 |
Unrealized Losses | (596,964) | (96,505) |
Fair Value | 128,847,404 | 51,949,641 |
Current | 93,787,733 | 35,830,211 |
Non-current | 35,059,671 | 16,119,430 |
Asset backed securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 89,554,665 | 45,468,482 |
Unrealized Gains | 204 | 0 |
Unrealized Losses | (661,833) | (249,440) |
Fair Value | 88,893,036 | 45,219,042 |
Current | 80,258,208 | 45,219,042 |
Non-current | 8,634,828 | 0 |
U.S. Government agency debt securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 52,186,023 | 42,715,195 |
Unrealized Gains | 0 | 0 |
Unrealized Losses | (144,716) | (137,433) |
Fair Value | 52,041,307 | 42,577,762 |
Current | 35,942,645 | 42,577,762 |
Non-current | $ 16,098,662 | $ 0 |
Cash, cash equivalents and in_5
Cash, cash equivalents and investments - Schedule of available-for-sale investments by maturity (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Amortized Cost | ||
Due within one year | $ 318,607,866 | $ 239,236,498 |
Due between one and five years | 60,168,427 | 16,123,253 |
Amortized Cost | 378,776,293 | 255,359,751 |
Fair Value | ||
Due within one year | 317,555,936 | 238,783,470 |
Due between one and five years | 59,793,161 | 16,119,430 |
Fair Value | $ 377,349,097 | $ 254,902,900 |
Cash, cash equivalents and in_6
Cash, cash equivalents and investments - Narrative (Details) - USD ($) | 3 Months Ended | 9 Months Ended |
Sep. 30, 2023 | Sep. 30, 2023 | |
Cash and Cash Equivalents [Abstract] | ||
Realized gain on available-for-sale debt investments | $ 611 | $ 611 |
Fair value measurements - Sched
Fair value measurements - Schedule of financial assets and liabilities measured at fair value on a recurring basis (Details) - USD ($) | 9 Months Ended | ||||
Oct. 02, 2023 | Jun. 01, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Available-for-sale debt securities: | $ 377,349,097 | $ 254,902,900 | |||
Purchase of note receivable | $ 5,000,000 | 5,000,000 | $ 0 | ||
Debt instrument, redemption price, percentage of principal and interest outstanding | 150% | ||||
Subsequent Event | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Purchase of note receivable | $ 5,000,000 | ||||
Fair Value, Recurring | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Total | 387,509,781 | 528,901,644 | |||
Fair Value, Recurring | Level 1 | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Total | 58,893,923 | 316,576,506 | |||
Fair Value, Recurring | Level 2 | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Total | 328,615,858 | 212,325,138 | |||
Fair Value, Recurring | Level 3 | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Total | 0 | 0 | |||
Commercial paper | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Available-for-sale debt securities: | 107,567,350 | 115,156,455 | |||
Commercial paper | Fair Value, Recurring | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Available-for-sale debt securities: | 107,567,350 | 115,156,455 | |||
Commercial paper | Fair Value, Recurring | Level 1 | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Available-for-sale debt securities: | 0 | 0 | |||
Commercial paper | Fair Value, Recurring | Level 2 | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Available-for-sale debt securities: | 107,567,350 | 115,156,455 | |||
Commercial paper | Fair Value, Recurring | Level 3 | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Available-for-sale debt securities: | 0 | 0 | |||
Corporate bonds | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Available-for-sale debt securities: | 128,847,404 | 51,949,641 | |||
Corporate bonds | Fair Value, Recurring | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Available-for-sale debt securities: | 128,847,404 | 51,949,641 | |||
Corporate bonds | Fair Value, Recurring | Level 1 | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Available-for-sale debt securities: | 0 | 0 | |||
Corporate bonds | Fair Value, Recurring | Level 2 | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Available-for-sale debt securities: | 128,847,404 | 51,949,641 | |||
Corporate bonds | Fair Value, Recurring | Level 3 | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Available-for-sale debt securities: | 0 | 0 | |||
Asset backed securities | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Available-for-sale debt securities: | 88,893,036 | 45,219,042 | |||
Asset backed securities | Fair Value, Recurring | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Available-for-sale debt securities: | 88,893,036 | 45,219,042 | |||
Asset backed securities | Fair Value, Recurring | Level 1 | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Available-for-sale debt securities: | 0 | 0 | |||
Asset backed securities | Fair Value, Recurring | Level 2 | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Available-for-sale debt securities: | 88,893,036 | 45,219,042 | |||
Asset backed securities | Fair Value, Recurring | Level 3 | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Available-for-sale debt securities: | 0 | 0 | |||
U.S. Government agency debt securities | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Available-for-sale debt securities: | 52,041,307 | 42,577,762 | |||
U.S. Government agency debt securities | Fair Value, Recurring | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Available-for-sale debt securities: | 52,041,307 | 42,577,762 | |||
U.S. Government agency debt securities | Fair Value, Recurring | Level 1 | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Available-for-sale debt securities: | 52,041,307 | 42,577,762 | |||
U.S. Government agency debt securities | Fair Value, Recurring | Level 2 | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Available-for-sale debt securities: | 0 | 0 | |||
U.S. Government agency debt securities | Fair Value, Recurring | Level 3 | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Available-for-sale debt securities: | 0 | 0 | |||
Money market mutual fund | Fair Value, Recurring | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Cash equivalents: | 6,852,616 | 273,998,744 | |||
Money market mutual fund | Fair Value, Recurring | Level 1 | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Cash equivalents: | 6,852,616 | 273,998,744 | |||
Money market mutual fund | Fair Value, Recurring | Level 2 | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Cash equivalents: | 0 | 0 | |||
Money market mutual fund | Fair Value, Recurring | Level 3 | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Cash equivalents: | 0 | 0 | |||
Commercial paper | Fair Value, Recurring | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Cash equivalents: | 3,308,068 | 0 | |||
Commercial paper | Fair Value, Recurring | Level 1 | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Cash equivalents: | 0 | 0 | |||
Commercial paper | Fair Value, Recurring | Level 2 | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Cash equivalents: | 3,308,068 | 0 | |||
Commercial paper | Fair Value, Recurring | Level 3 | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Cash equivalents: | $ 0 | $ 0 |
Prepaid expenses and other cu_3
Prepaid expenses and other current assets (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Prepaid Expense and Other Assets, Current [Abstract] | ||
Prepaid clinical trial expenses | $ 2,812,270 | $ 4,011,419 |
Prepaid insurance | 1,390,347 | 1,310,314 |
Receivable on matured short-term investment | 5,000,000 | 0 |
Canadian harmonized sales tax receivable | 206,326 | 60,222 |
Deposit on production equipment | 0 | 13,738 |
Other | 492,786 | 215,196 |
Total | $ 9,901,729 | $ 5,610,889 |
Property, plant and equipment_3
Property, plant and equipment, net (Details) ft² in Thousands | Sep. 30, 2023 USD ($) | Dec. 31, 2022 USD ($) | Jul. 31, 2020 ft² |
Property, Plant and Equipment [Line Items] | |||
Facility lease | $ 5,384,707 | $ 0 | |
Total property, plant and equipment, gross | 57,623,635 | 32,775,605 | |
Less: Accumulated depreciation | (3,581,282) | (1,395,029) | |
Total | 54,042,353 | 31,380,576 | |
Good Manufacturing Practices | |||
Property, Plant and Equipment [Line Items] | |||
Square-foot of building | ft² | 81 | ||
Land and building | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant and equipment, gross | 19,992,990 | 18,163,962 | |
Machinery and equipment | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant and equipment, gross | 11,241,336 | 5,328,639 | |
Property, plant and equipment, in development | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant and equipment, gross | 19,827,730 | 8,434,384 | |
Furniture and fixtures | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant and equipment, gross | 938,909 | 698,728 | |
Computer equipment | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant and equipment, gross | $ 237,963 | $ 149,892 |
Property, plant and equipment_4
Property, plant and equipment, net - Estimated Useful Life (Details) | Sep. 30, 2023 |
Computer equipment | |
Property, Plant and Equipment [Line Items] | |
Estimated Useful Life | 5 years |
Machinery and equipment | |
Property, Plant and Equipment [Line Items] | |
Estimated Useful Life | 7 years |
Furniture and fixtures | |
Property, Plant and Equipment [Line Items] | |
Estimated Useful Life | 7 years |
Facility lease | |
Property, Plant and Equipment [Line Items] | |
Estimated Useful Life | 7 years |
Building | |
Property, Plant and Equipment [Line Items] | |
Estimated Useful Life | 20 years |
Accrued liabilities (Details)
Accrued liabilities (Details) - USD ($) | Sep. 30, 2023 | Dec. 31, 2022 |
Accrued Liabilities, Current [Abstract] | ||
Accrued personnel costs | $ 5,663,218 | $ 7,116,382 |
Accrued research and development costs | 7,766,189 | 9,645,594 |
Accrued corporate legal fees and other professional services | 907,019 | 2,068,793 |
Accrued costs for purchases of property, plant and equipment | 75,360 | 105,741 |
Other accrued costs | 117,568 | 157,944 |
Total | $ 14,529,354 | $ 19,094,454 |
Leases - Narrative (Details)
Leases - Narrative (Details) | Apr. 12, 2023 | Mar. 10, 2023 ft² renewal | Feb. 02, 2023 ft² people |
Lessee, Lease, Description [Line Items] | |||
Percentage of fair value | 0.90 | ||
UHN | |||
Lessee, Lease, Description [Line Items] | |||
Net rentable area | 7,700 | ||
Initial lease term | 5 years | ||
Renewal term | 2 years | ||
UHN | Minimum | |||
Lessee, Lease, Description [Line Items] | |||
Number of people required in committee | people | 6 | ||
Indianapolis Lease | |||
Lessee, Lease, Description [Line Items] | |||
Net rentable area | 103,000 | ||
Initial lease term | 121 months | ||
Renewal term | 10 years | ||
Number of renewal options | renewal | 2 | ||
Labratory Space | |||
Lessee, Lease, Description [Line Items] | |||
Initial lease term | 2 years |
Leases - Schedule of Lease Expe
Leases - Schedule of Lease Expense (Details) - USD ($) | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Leases [Abstract] | ||
Operating lease expense | $ 303,215 | $ 0 |
Amortization of right-of-use asset | 384,622 | |
Interest on lease liability | 196,027 | |
Total finance lease cost | $ 580,649 | $ 0 |
Leases - Supplemental Cash Flow
Leases - Supplemental Cash Flow Information (Details) - USD ($) | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Cash paid for amounts included in the measurement of lease liabilities: | ||
Operating cash flow use from operating leases | $ 167,397 | |
Operating cash flow use from finance lease | 196,027 | |
Payments on finance lease | 285,949 | $ 0 |
Right-of-use assets obtained in exchange for lease obligations: | ||
Operating leases | 5,644,563 | |
Finance lease | $ 5,384,707 |
Leases - Weighted Average Remai
Leases - Weighted Average Remaining Lease Term and Discount Rates (Details) | Sep. 30, 2023 |
Weighted-average remaining lease term (in years): | |
Operating leases | 9 years 2 months 12 days |
Finance lease | 6 years 6 months |
Weighted-average discount rates: | |
Operating leases | 7.80% |
Finance lease | 7.70% |
Leases - Operating Lease Maturi
Leases - Operating Lease Maturity (Details) | Sep. 30, 2023 USD ($) |
Operating Leases | |
2023 | $ 232,797 |
2024 | 689,632 |
2025 | 797,739 |
2026 | 746,332 |
2027 | 768,722 |
Thereafter | 4,732,515 |
Total lease payments | 7,967,737 |
Less: imputed interest | (2,385,189) |
Present value of lease liabilities | 5,582,548 |
Finance Lease | |
2023 | 246,755 |
2024 | 987,018 |
2025 | 987,018 |
2026 | 987,018 |
2027 | 987,018 |
Thereafter | 2,220,793 |
Total lease payments | 6,415,620 |
Less: imputed interest | (1,335,399) |
Present value of lease liabilities | $ 5,080,221 |
Stockholders' equity (Details)
Stockholders' equity (Details) | 3 Months Ended | 9 Months Ended | ||||||||
Sep. 30, 2023 USD ($) $ / shares shares | Jun. 30, 2023 shares | Mar. 31, 2023 shares | Sep. 30, 2022 USD ($) $ / shares shares | Jun. 30, 2022 shares | Mar. 31, 2022 shares | Sep. 30, 2023 USD ($) vote $ / shares shares | Sep. 30, 2022 USD ($) $ / shares shares | Dec. 31, 2022 $ / shares shares | Dec. 31, 2021 shares | |
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||
Common stock, authorized (in shares) | 430,000,000 | 430,000,000 | 430,000,000 | |||||||
Common shares, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | $ 0.0001 | |||||||
Number of shares issued during period (in shares) | 0 | |||||||||
Proceeds from issuance of shares of common stock | $ | $ 0 | $ 116,856,162 | ||||||||
Cost and fees on issuance of common shares | $ | $ 8,200,000 | |||||||||
Common stock, shares issued (in shares) | 105,765,954 | 105,765,954 | 105,649,741 | |||||||
Common stock, shares outstanding (in shares) | 105,765,954 | 105,765,954 | 105,649,741 | |||||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | 0 | |||||||
Preferred stock, shares issued (in shares) | 0 | 0 | 0 | |||||||
Number of votes per share | vote | 1 | |||||||||
Cash dividend declared | $ | $ 0 | 0 | $ 0 | 0 | ||||||
Cash dividend paid | $ | $ 0 | $ 0 | $ 0 | $ 0 | ||||||
Public Share Offering | ||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||
Sale of stock, price per share (in dollars per share) | $ / shares | $ 9 | $ 9 | ||||||||
Preferred shares | ||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||
Preferred shares, shares authorized (in shares) | 20,000,000 | 20,000,000 | ||||||||
Preferred stock, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | ||||||||
Number of shares issued during period (in shares) | 0 | |||||||||
Common Stock | ||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||
Number of shares issued during period (in shares) | 13,900,000 | 13,933,168 | ||||||||
Issuance of shares of common stock in connection with stock option exercises (in shares) | 83,277 | 32,936 | 30,000 | 2,490 | 678 | |||||
Proceeds from issuance of shares of common stock | $ | $ 125,100,000 | |||||||||
Issuance of common stock in connection with an underwritten public share offering and exercise of stock options (in shares) | 13,930,000 | |||||||||
Common stock, shares outstanding (in shares) | 105,765,954 | 105,765,954 | 105,682,677 | 104,054,962 | 90,124,962 | 90,122,472 | 105,765,954 | 104,054,962 | 105,649,741 | 90,121,794 |
Common Stock | Non-employee consultant | ||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||
Issuance of shares of common stock in connection with stock option exercises (in shares) | 86,585 | 3,168 | ||||||||
Proceeds from issuance of shares of common stock | $ | $ 41,700 | $ 120,353 | $ 4,403 | |||||||
Common Stock | Board member | ||||||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||||||||
Issuance of shares of common stock in connection with stock option exercises (in shares) | 29,628 | |||||||||
Proceeds from issuance of shares of common stock | $ | $ 211,569 |
Stock-based compensation - Narr
Stock-based compensation - Narrative (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||
Jan. 01, 2023 | Jun. 06, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Annual increase in shares authorized, percentage | 4% | ||||||
Number of additional shares available (in shares) | 4,225,990 | ||||||
Number of shares authorized for issuance under plan (in shares) | 9,049,548 | 9,049,548 | |||||
Proceeds from issuance of shares of common stock | $ 0 | $ 116,856,162 | |||||
Unrecognized stock-based compensation | $ 17,944,644 | $ 17,944,644 | |||||
Period for recognition | 2 years 10 months 24 days | ||||||
Non-employee consultant | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Proceeds from issuance of shares of common stock | $ 41,700 | $ 331,922 | $ 46,103 | ||||
Vesting on 1st year anniversary | Employees and Directors | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Vesting percentage | 25% | ||||||
Vesting ratably over the remaining three years | Employees and Directors | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Vesting percentage | 75% | ||||||
Stock options | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Number of options granted (in shares) | 0 | 3,294,071 | |||||
Stock options exercised (in shares) | 0 | 116,213 | |||||
Stock options | Employee | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Number of options granted (in shares) | 150,000 | ||||||
Options granted in period, weighted average grant date fair value (in dollars per share) | $ 4.57 | ||||||
Stock options | Employees and Directors | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Number of options granted (in shares) | 3,144,071 | 1,948,614 | |||||
Options granted in period, weighted average grant date fair value (in dollars per share) | $ 3.85 | $ 4.59 | |||||
Stock options exercised (in shares) | 29,628 | ||||||
Intrinsic value | $ 38,300 | ||||||
Stock options | Director | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Number of options granted (in shares) | 128,070 | ||||||
Vesting period | 1 year | ||||||
Stock options | Non-employee consultant | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Stock options exercised (in shares) | 30,000 | 86,585 | 33,168 | ||||
Intrinsic value | $ 238,300 | $ 700,217 | $ 257,601 | ||||
Stock options | Vesting on 1st year anniversary | Employee | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Vesting percentage | 25% | ||||||
Vesting period | 1 year | ||||||
Stock options | Vesting on 1st year anniversary | Employees and Directors | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Vesting period | 1 year | ||||||
Stock options | Vesting on 1st year anniversary | Director | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Vesting period | 1 year | ||||||
Stock options | Vesting ratably over the remaining three years | Employee | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Vesting percentage | 75% | ||||||
Vesting period | 3 years | 3 years | |||||
Stock options | Vesting ratably over the remaining three years | Employees and Directors | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Vesting period | 3 years | ||||||
Performance Shares | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Vesting percentage | 100% | ||||||
Grants in period (in shares) | 146,044 | ||||||
Grant date fair value (in dollars per share) | $ 6.61 | ||||||
Research and development | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Share-based compensation expense | $ 666,368 | 476,481 | $ 1,797,759 | $ 1,220,426 | |||
General and administrative | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Share-based compensation expense | $ 1,210,064 | $ 602,575 | $ 2,798,518 | $ 1,326,643 |
Stock-based compensation - Summ
Stock-based compensation - Summarizes activity relating to options to purchase stock (Details) - Stock options - $ / shares | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | |
Number of Shares | |||
Beginning balance (in shares) | 5,592,173 | ||
Granted (in shares) | 0 | 3,294,071 | |
Exercised (in shares) | 0 | (116,213) | |
Forfeited (in shares) | (176,942) | ||
Expired (in shares) | (15,510) | ||
Ending balance (in shares) | 8,577,579 | 8,577,579 | |
Vested and expected to vest (in shares) | 8,577,579 | 8,577,579 | |
Options exercisable (in shares) | 2,985,114 | 2,985,114 | |
Weighted Average Exercise Price Per Share ($) | |||
Beginning balance (in dollars per share) | $ 5.85 | ||
Granted (in dollars per share) | 7.09 | ||
Exercised (in dollars per share) | 2.86 | ||
Forfeited (in dollars per share) | 7.23 | ||
Expired (in dollars per share) | 8.29 | ||
Ending balance (in dollars per share) | $ 6.33 | 6.33 | |
Vested and expected to vest (in dollars per share) | 6.33 | 6.33 | |
Options exercisable (in dollars per share) | $ 5.19 | $ 5.19 | |
Weighted- Average Remaining Contractual Term (in years) | |||
Outstanding (in years) | 4 years 4 months 24 days | ||
Vested and expected to vest (in years) | 4 years 4 months 24 days | ||
Options exercisable (in years) | 3 years 8 months 12 days |
Stock-based compensation - Assu
Stock-based compensation - Assumptions used in Black-Scholes-Merton option-pricing model (Details) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Risk-free interest rate | 4.47% | 0% | ||
Expected term (in years) | 4 years 3 months | |||
Expected volatility | 66% | 0% | ||
Expected dividend yield | 0% | 0% | 0% | 0% |
Minimum | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Risk-free interest rate | 0.0371% | 0.0124% | ||
Expected term (in years) | 3 years 6 months | 4 years 3 months | ||
Expected volatility | 0.66% | 0.72% | ||
Maximum | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Risk-free interest rate | 0.0447% | 0.0313% | ||
Expected term (in years) | 4 years 3 months | |||
Expected volatility | 0.68% | 0.75% |
Commitments and contingencies -
Commitments and contingencies - Property in development commitment (Details) - Property, in development commitment - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Other Commitments [Line Items] | ||||
Future payments relating to the construction and retrofit of the building | $ 22.5 | $ 22.5 | ||
Total aggregate remaining minimum commitment | $ 5.2 | $ 3.7 | $ 15.5 | $ 7.7 |
Commitments and contingencies_2
Commitments and contingencies - Clinical trial and commercial commitments & License agreements (Details) € in Millions, $ in Millions | 3 Months Ended | 9 Months Ended | |||||||
Sep. 25, 2023 USD ($) | Sep. 25, 2023 EUR (€) | May 10, 2023 USD ($) | Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) | Sep. 30, 2023 CAD ($) | Sep. 30, 2022 USD ($) | Sep. 11, 2023 USD ($) | |
Athebio | Stock Purchase Agreement | |||||||||
Long-term Purchase Commitment [Line Items] | |||||||||
Investment committed | $ 5,000,000 | ||||||||
Research and development | Athebio | |||||||||
Long-term Purchase Commitment [Line Items] | |||||||||
Total aggregate remaining minimum commitment | $ 1,000,000 | $ 1,000,000 | |||||||
Research and development | License Agreement | |||||||||
Long-term Purchase Commitment [Line Items] | |||||||||
Total aggregate remaining minimum commitment | 1,500,000 | $ 800,000 | 5,000,000 | $ 5,300,000 | |||||
Supply agreements in connection with clinical trials | |||||||||
Long-term Purchase Commitment [Line Items] | |||||||||
Total aggregate remaining minimum commitment | 5,400,000 | ||||||||
Supply agreements in connection | Research and development | |||||||||
Long-term Purchase Commitment [Line Items] | |||||||||
Total aggregate remaining minimum commitment | 3,100,000 | 3,800,000 | 14,400,000 | 8,100,000 | |||||
Supply agreement to purchase certain products | |||||||||
Long-term Purchase Commitment [Line Items] | |||||||||
Term for total aggregate remaining minimum commitment | 10 years | ||||||||
Minimum purchase commitments | $ 32,400,000 | 109,200,000 | $ 148.3 | ||||||
Supply agreement to purchase certain products | Research and development | |||||||||
Long-term Purchase Commitment [Line Items] | |||||||||
Total aggregate remaining minimum commitment | 0 | 0 | |||||||
Minimum purchase commitments | 0 | 0 | 0 | 0 | |||||
Supply Agreement To Purchase n.c.a. Lu | |||||||||
Long-term Purchase Commitment [Line Items] | |||||||||
Term for total aggregate remaining minimum commitment | 10 years | 10 years | |||||||
Minimum purchase commitments | $ 107,400,000 | € 101.8 | |||||||
Supply Agreement To Purchase n.c.a. Lu | Research and development | |||||||||
Long-term Purchase Commitment [Line Items] | |||||||||
Minimum purchase commitments | 200,000 | 200,000 | |||||||
Agreement in connection with the SPLASH clinical phase study | |||||||||
Long-term Purchase Commitment [Line Items] | |||||||||
Total aggregate remaining minimum commitment | 23,700,000 | ||||||||
Agreement in connection with the SPLASH clinical phase study | Research and development | |||||||||
Long-term Purchase Commitment [Line Items] | |||||||||
Total aggregate remaining minimum commitment | $ 3,500,000 | $ 6,500,000 | $ 14,600,000 | $ 15,400,000 | |||||
Maximum | Supply agreements in connection with clinical trials | |||||||||
Long-term Purchase Commitment [Line Items] | |||||||||
Term for total aggregate remaining minimum commitment | 8 years | 8 years | |||||||
Maximum | Supply agreement to purchase certain products | |||||||||
Long-term Purchase Commitment [Line Items] | |||||||||
Term for total aggregate remaining minimum commitment | 9 years | 9 years | |||||||
Maximum | Agreement in connection with the SPLASH clinical phase study | |||||||||
Long-term Purchase Commitment [Line Items] | |||||||||
Term for total aggregate remaining minimum commitment | 5 years | 5 years | |||||||
Minimum | Supply agreements in connection with clinical trials | |||||||||
Long-term Purchase Commitment [Line Items] | |||||||||
Term for total aggregate remaining minimum commitment | 3 years | 3 years | |||||||
Minimum | Supply agreement to purchase certain products | |||||||||
Long-term Purchase Commitment [Line Items] | |||||||||
Term for total aggregate remaining minimum commitment | 2 years | 2 years | |||||||
Minimum | Agreement in connection with the SPLASH clinical phase study | |||||||||
Long-term Purchase Commitment [Line Items] | |||||||||
Term for total aggregate remaining minimum commitment | 1 year | 1 year |
Net loss per share - Summary of
Net loss per share - Summary of basic and diluted net loss per share (Details) - USD ($) | 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 | |
Earnings Per Share [Abstract] | ||||||||
Net loss | $ 24,774,353 | $ 25,410,839 | $ 16,530,671 | $ 24,013,069 | $ 24,580,247 | $ 16,380,574 | $ 66,715,863 | $ 64,973,890 |
Weighted-average common shares outstanding - basic (in shares) | 105,765,954 | 92,401,484 | 105,717,330 | 90,891,031 | ||||
Weighted-average common shares outstanding - diluted (in shares) | 105,765,954 | 92,401,484 | 105,717,330 | 90,891,031 | ||||
Net loss per share - basic (in dollars per share) | $ 0.23 | $ 0.26 | $ 0.63 | $ 0.71 | ||||
Net loss per share - diluted (in dollars per share) | $ 0.23 | $ 0.26 | $ 0.63 | $ 0.71 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Income Tax Disclosure [Abstract] | ||||
Income tax (benefit) expense | $ 871,449 | $ 180,500 | $ (288,491) | $ 452,021 |
Related party transactions - Sc
Related party transactions - Schedule of Related Party Transactions (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Related Party Transaction [Line Items] | ||||
Related party expenses | $ 108,380 | $ 107,435 | $ 349,604 | $ 312,203 |
Consulting fees on business activities to Board member | ||||
Related Party Transaction [Line Items] | ||||
Related party expenses | 90,161 | 90,040 | 296,072 | 259,132 |
Reimbursement to Board member for occupancy costs | ||||
Related Party Transaction [Line Items] | ||||
Related party expenses | $ 18,219 | $ 17,395 | $ 53,532 | $ 53,071 |
Related party transactions -Nar
Related party transactions -Narrative (Details) - USD ($) | 9 Months Ended | |
Sep. 30, 2023 | Dec. 31, 2022 | |
Related Party Transaction [Line Items] | ||
Accrued liabilities | $ 14,529,354 | $ 19,094,454 |
Director | ||
Related Party Transaction [Line Items] | ||
Accrued liabilities | 43,859 | |
Related Party | ||
Related Party Transaction [Line Items] | ||
Rent expense | $ 6,000 |
Subsequent events (Details)
Subsequent events (Details) - USD ($) | 9 Months Ended | ||||
Oct. 02, 2023 | Jun. 01, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | Oct. 13, 2023 | |
Subsequent Event [Line Items] | |||||
Purchase of note receivable | $ 5,000,000 | $ 5,000,000 | $ 0 | ||
Subsequent Event | |||||
Subsequent Event [Line Items] | |||||
Purchase of note receivable | $ 5,000,000 | ||||
Termination fee | $ 54,400,000 | ||||
Subsequent Event | Eli Lilly | |||||
Subsequent Event [Line Items] | |||||
Business acquisition, share price (in dollars per share) | $ 12.50 |