Cover
Cover - shares | 3 Months Ended | |
Mar. 31, 2023 | May 10, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 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 | 105,693,356 | |
Entity Central Index Key | 0001811764 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q1 | |
Amendment Flag | false |
Interim Condensed Consolidated
Interim Condensed Consolidated Balance Sheets - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Current assets | ||
Cash and cash equivalents | $ 111,139,617 | $ 286,428,371 |
Short-term investments | 318,893,583 | 238,783,470 |
Prepaid expenses and other current assets | 4,546,707 | 5,610,889 |
Total current assets | 434,579,907 | 530,822,730 |
Non-current assets | ||
Long-term investments | 89,170,335 | 16,119,430 |
Property, plant and equipment, net | 34,773,967 | 31,380,576 |
Total non-current assets | 123,944,302 | 47,500,006 |
Total assets | 558,524,209 | 578,322,736 |
Current liabilities | ||
Accounts payable | 15,918,532 | 7,703,150 |
Accrued liabilities | 16,615,066 | 19,094,454 |
Deferred revenue | 16,518,934 | 23,242,290 |
Income taxes payable | 28,795,306 | 29,698,546 |
Total current liabilities | 77,847,838 | 79,738,440 |
Long-term income taxes payable | 1,452,356 | 1,452,356 |
Deferred revenue, net of current portion | 7,444,239 | 10,178,147 |
Total liabilities | 86,744,433 | 91,368,943 |
Commitments and contingencies (Note 11) | ||
Stockholders’ equity | ||
Common Stock, par value $0.0001 per share, 430,000,000 authorized, 105,682,677 and 105,649,741 issued and outstanding as of March 31, 2023 and December 31, 2022, respectively | 10,568 | 10,565 |
Additional paid-in capital | 449,546,931 | 448,391,574 |
Retained earnings | 22,477,834 | 39,008,505 |
Accumulated other comprehensive loss | (255,557) | (456,851) |
Total stockholders’ equity | 471,779,776 | 486,953,793 |
Total liabilities and stockholders’ equity | $ 558,524,209 | $ 578,322,736 |
Interim Condensed Consolidate_2
Interim Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 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) | 105,682,677 | 105,649,741 |
Common stock, shares outstanding (in shares) | 105,682,677 | 105,649,741 |
Unaudited Interim Condensed Con
Unaudited Interim Condensed Consolidated Statements of Operations - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Revenue | ||
Total revenue | $ 9,457,264 | $ 0 |
Operating expenses | ||
Research and development | 26,910,472 | 12,500,848 |
General and administrative | 5,010,129 | 3,807,942 |
Total operating expenses | 31,920,601 | 16,308,790 |
Loss from operations | (22,463,337) | (16,308,790) |
Other income (expenses) | ||
Investment income | 5,764,214 | 47,973 |
Foreign currency loss | (70,190) | (31,641) |
Total other income (expenses) | 5,694,024 | 16,332 |
Loss before income taxes | (16,769,313) | (16,292,458) |
Income tax benefit (provision) | 238,642 | (88,116) |
Net loss | $ (16,530,671) | $ (16,380,574) |
Net loss per basic and diluted common share: | ||
Basic net loss per common share (in dollars per share) | $ (0.16) | $ (0.18) |
Diluted net loss per common share (in dollars per share) | $ (0.16) | $ (0.18) |
Basic weighted average common shares outstanding (in shares) | 105,660,655 | 90,122,269 |
Diluted weighted average common shares outstanding (in shares) | 105,660,655 | 90,122,269 |
Unaudited Condensed Consolidate
Unaudited Condensed Consolidated Statements of Comprehensive Loss - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Statement of Comprehensive Income [Abstract] | ||
Net loss | $ (16,530,671) | $ (16,380,574) |
Other comprehensive income, net of tax | ||
Net unrealized gain on available-for-sale debt securities | 201,294 | 0 |
Total comprehensive loss | $ (16,329,377) | $ (16,380,574) |
Unaudited Interim Condensed C_2
Unaudited Interim Condensed Consolidated Statements of Stockholders' Equity - USD ($) | Total | Common Stock | Additional Paid-in Capital | Retained Earnings | 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, 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, net of tax | $ 201,294 | 201,294 | |||
Ending balance (in shares) at Mar. 31, 2023 | 105,682,677 | 105,682,677 | |||
Ending balance at Mar. 31, 2023 | $ 471,779,776 | $ 10,568 | $ 449,546,931 | $ 22,477,834 | $ (255,557) |
Unaudited Interim Condensed C_3
Unaudited Interim Condensed Consolidated Statements of Cash Flows - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Cash flows from operating activities | ||
Net loss: | $ (16,530,671) | $ (16,380,574) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation on property, plant and equipment | 537,627 | 224,234 |
Stock-based compensation expense | 1,009,496 | 440,450 |
Amortization of premiums (accretion of discounts) on investments, net | (3,159,749) | 0 |
Changes in operating assets and liabilities | ||
Prepaid expenses and other current assets | 1,064,182 | (197,829) |
Accounts payable | 7,744,626 | 3,920,227 |
Accrued liabilities | (2,414,883) | 1,424,963 |
Deferred revenue | (9,457,264) | 0 |
Income taxes payable | (903,240) | 77,925 |
Change in accrued interest and dividends within investments | (281,465) | 0 |
Net cash used in operating activities | (22,391,341) | (10,490,604) |
Cash flows from investing activities | ||
Purchase of investments, net of sales and maturities | (149,518,510) | 0 |
Purchase of property, plant and equipment | (3,524,767) | (940,931) |
Net cash used in investing activities | (153,043,277) | (940,931) |
Cash flows from financing activities | ||
Issuance of shares of Common Stock in connection with stock option exercises | 145,864 | 942 |
Net cash provided by financing activities | 145,864 | 942 |
Net decrease in cash and cash equivalents | (175,288,754) | (11,430,593) |
Cash and cash equivalents, beginning of period | 286,428,371 | 238,815,991 |
Cash and cash equivalents, end of period | 111,139,617 | 227,385,398 |
Supplemental disclosure of cash flow information: | ||
Cash paid for income taxes | (660,786) | (116) |
Non-cash investment activities: | ||
Purchase of property, plant and equipment recorded in accounts payable and accrued liabilities | $ 1,815,752 | $ 1,052,186 |
Nature of business
Nature of business | 3 Months Ended |
Mar. 31, 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 | 3 Months Ended |
Mar. 31, 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, 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 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 years ended December 31, 2022 and 2021, 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. Impact of COVID-19 Pandemic and other geopolitical events The COVID-19 pandemic has caused many governments to implement measures to slow the spread of the outbreak through quarantines, travel restrictions, heightened border security and other measures. The U.S. Department of Health and Human Services let the public health emergency declaration for COVID-19 expire on May 11, 2023 and the World Health Organization ended the global emergency status for COVID-19 on May 5, 2023. Although the impact has lessened and many of the protective measures associated therewith have been terminated, COVID-19 may continue to affect the global economy as well as businesses and capital markets around the world. Further, general macroeconomic trends, including rising inflation rates, rising interest rates, as well as recent and potential future disruptions in access to bank deposits or lending commitments due to bank failure, sustained supply chain disruptions, and any resulting recession, depression or other sustained adverse market event could materially and adversely affect our business, financial condition, results of operations and the value of our Common Stock (as defined below). Additionally, financial markets may be adversely affected by the current or anticipated impact of military conflict, including escalating military fighting between Russia and Ukraine, terrorism, bank failures or other or macroeconomic geopolitical events. The U.S. and other nations in response to the Russo-Ukrainian conflict have announced economic sanctions which may have an adverse effect on the global financial markets. 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 has vendor staff in Ukraine, and any political instability in the region may disrupt resourcing assigned to the trial and negatively impact our business. The Company is monitoring the potential impact of the COVID-19 pandemic, the Russo-Ukrainian conflict, bank failures and other macroeconomic 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. Risks and uncertainties Prior to the Lantheus License Agreements (as defined in Note 3 below), the Company had incurred significant net losses and had funded operations primarily through equity financings. Operating losses and negative cash flows were incurred in the quarter ended March 31, 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 the COVID-19 coronavirus, the Russo-Ukrainian conflict 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. 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 to the performance obligations under the Lantheus License Agreements, the accrual of research and development expenses and the valuations of stock options. 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 experience. Changes in estimates are recorded in the period in which they become known. Actual results may differ from those estimates or assumptions. Recent accounting pronouncements The Company has evaluated accounting pronouncements recently issued but not yet adopted and believes that the current 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 | 3 Months Ended |
Mar. 31, 2023 | |
Revenue from Contract with Customer [Abstract] | |
Revenue | Revenue In November 2022, POINT announced strategic collaboration and exclusive license agreements with Lantheus Holdings Inc. ("Lantheus") for exclusive worldwide rights for PNT2002 and PNT2003, excluding certain territories (Japan, South Korea, Singapore, Indonesia, and China including Hong Kong, Macau and Taiwan) (the "PNT2002 Agreement" and "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 transaction, including Hart-Scott-Rodino antitrust clearance, 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 million upfront payment under the PNT2003 Agreement, and will receive up to an additional $30 million upon U.S. regulatory approval. The PNT2003 Agreement also provides that POINT 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. The Company is responsible for completing the 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 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 adjusted market and expected cost plus a margin assessments, 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 relate 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 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 adjusted market and expected cost plus a margin assessments, 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 relate 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 their 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 March 31, 2023 and December 31, 2022 : March 31, 2023 December 31, 2022 Deferred revenue Deferred revenue, current $ 16,518,934 $ 23,242,290 Deferred revenue, net of current portion 7,444,239 10,178,147 Total $ 23,963,173 $ 33,420,437 At inception of the Lantheus License Agreements, deferred revenue $34.8 million was recognized in connection with future performance. During the quarter ended March 31, 2023 , the Company recognized $9.5 million in revenue for services performed (March 31, 2022 - $nil). 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 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 | 3 Months Ended |
Mar. 31, 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 March 31, 2023 As of December 31, 2022 Cash $ 19,393,396 $ 12,429,627 Cash equivalents: Money market funds 91,746,221 273,998,744 Total cash and cash equivalents 111,139,617 286,428,371 Short-term investments Commercial paper 159,747,972 115,156,455 Corporate bonds 67,096,233 45,219,042 U.S. Government agency debt securities 58,250,793 42,577,762 Asset backed securities 33,798,585 35,830,211 Total short-term investments 318,893,583 238,783,470 Long-term investments Asset backed securities 48,352,696 16,119,430 Corporate bonds 40,817,639 — Total long-term investments 89,170,335 16,119,430 Total cash, cash equivalents and investments $ 519,203,535 $ 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 March 31, 2023 were as follows: Amortized Cost Unrealized Gains Unrealized Losses Fair Value Current Non-current Commercial paper $ 159,747,972 $ — $ — $ 159,747,972 $ 159,747,972 $ — Corporate bonds 108,167,585 15,551 $ (269,264) 107,913,872 67,096,233 40,817,639 Asset backed securities 82,135,898 74,656 (59,273) 82,151,281 33,798,585 48,352,696 U.S. Government agency debt securities 58,268,020 27,511 (44,738) 58,250,793 58,250,793 — Total available-for-sale securities $ 408,319,475 $ 117,718 $ (373,275) $ 408,063,918 $ 318,893,583 $ 89,170,335 The following table summarizes the fair value of available-for-sale investments based on stated contractual maturities as of March 31, 2023: Amortized Cost Fair Value Due within one year $ 319,134,902 $ 318,893,583 Due between one and five years 89,184,573 89,170,335 Total $ 408,319,475 $ 408,063,918 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 months ended March 31, 2023, we had no realized gains or losses, on available-for-sale investments. |
Fair value measurements
Fair value measurements | 3 Months Ended |
Mar. 31, 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 March 31, 2023 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 (in thousands): Level 1 Level 2 Level 3 Total March 31, 2023 Cash equivalents: Money market mutual fund $ 91,746,221 $ — $ — $ 91,746,221 Available-for-sale debt securities: Commercial paper — 159,747,972 — 159,747,972 Corporate bonds — 107,913,872 — 107,913,872 Asset backed securities — 82,151,281 — 82,151,281 U.S. Government agency debt securities 58,250,793 — — 58,250,793 Total $ 149,997,014 $ 349,813,125 $ — $ 499,810,139 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. We did not have any financial liabilities measured at fair value on a recurring basis as of March 31, 2023. There have been no transfers of assets or liabilities between the fair value measurement levels. |
Prepaid expenses and other curr
Prepaid expenses and other current assets | 3 Months Ended |
Mar. 31, 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 March 31, 2023 As of December 31, 2022 $ $ Prepaid clinical trial expenses 3,339,239 4,011,419 Prepaid insurance 859,141 1,310,314 Canadian harmonized sales tax receivable 159,045 60,222 Other 189,282 228,934 Total 4,546,707 5,610,889 |
Property, plant and equipment,
Property, plant and equipment, net | 3 Months Ended |
Mar. 31, 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 March 31, 2023 As of December 31, 2022 $ $ Land and building 18,451,207 18,163,962 Machinery and equipment 9,015,960 5,328,639 Property, plant and equipment, in development 8,367,969 8,434,384 Furniture and fixtures 721,595 698,728 Computer equipment 149,892 149,892 36,706,623 32,775,605 Less: Accumulated depreciation (1,932,656) (1,395,029) Total 34,773,967 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, Good Manufacturing Practices ("GMP") 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 Building 20 years |
Accrued expenses
Accrued expenses | 3 Months Ended |
Mar. 31, 2023 | |
Accrued Liabilities, Current [Abstract] | |
Accrued expenses | Accrued expenses Accrued liabilities consisted of the following: As of March 31, 2023 As of December 31, 2022 $ $ Accrued personnel costs 7,660,395 7,116,382 Accrued research and development costs 7,174,563 9,645,594 Accrued corporate legal fees and other professional services 1,536,575 2,068,793 Accrued costs for purchases of property, plant and equipment 41,236 105,741 Other accrued costs 202,297 157,944 Total 16,615,066 19,094,454 |
Stockholders' equity
Stockholders' equity | 3 Months Ended |
Mar. 31, 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 March 31, 2023, the Company issued (a) 15,000 shares of Common Stock in connection with the exercise of stock options granted to a non-employee consultant, resulting in total cash proceeds of $20,850 and (b) 17,936 shares of Common Stock in connection with the exercise of stock options granted to a board member, resulting in total cash proceeds of $125,014. During the three months ended March 31, 2022, the Company issued 678 shares of Common Stock issued in connection with the exercise of stock options issued to a non-employee consultant, resulting in total cash proceeds of $942. As of March 31, 2023, the number of total issued and outstanding shares of Common Stock was 105,682,677 (December 31, 2022 – 105,649,741). As of March 31, 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. Common stockholders are entitled to receive dividends, if any, as may be declared by the Company’s board of directors. During the three months ended March 31, 2023, no cash dividends were declared or paid by the Company (March 31, 2022 — $nil). The Company’s board of directors 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 three months ended March 31, 2023, no shares of Preferred Stock were issued by the Company. |
Stock-based compensation
Stock-based compensation | 3 Months Ended |
Mar. 31, 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 Company’s board of directors 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 Company's board of directors. 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 9,344,912 shares of Common Stock authorized for issuance under the 2021 EIP as of March 31, 2023. Stock options The Company recorded $446,128 to research and development expense and $563,368 to general and administrative expenses for stock-based compensation for the three months ended March 31, 2023 (March 31, 2022 — $285,311 to research and development expense and $155,139 to general and administrative expenses for the three months ended). The Company did not recognize a tax benefit related to stock-based compensation expense during the three months ended March 31, 2023, 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 2,839,823 6.78 Exercised (32,936) 4.43 Forfeited (33,693) 8.25 Expired (9,546) 8.47 Outstanding as of March 31, 2023 8,355,821 6.16 4.8 Vested and expected to vest as of March 31, 2023 8,355,821 6.16 4.8 Options exercisable as of March 31, 2023 2,635,805 4.61 4.7 During the three months ended March 31, 2023, 2,839,823 stock options were granted to employees and directors of the Company, with a weighted average grant date fair value of $3.76. 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 During the three months ended March 31, 2022, 1,705,197 stock options were granted to employees and directors of the Company, with a weighted average grant date fair value of $4.58. 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 March 31, 2023 Three months ended March 31, 2022 Risk-free interest rate 3.71% 1.24% - 2.51% Expected term (in years) 4.25 4.25 Expected volatility 68% 72% - 73% Expected dividend yield — — During the three months ended March 31, 2023, non-employee consultants of the Company exercised 15,000 stock options with an intrinsic value of $95,450 and a board member of the Company exercised 17,936 stock options with an intrinsic value of $5,560. The exercises resulted in cash proceeds to the Company of $20,850 and $125,014, respectively. During the three months ended March 31, 2022, a non-employee consultant of the Company exercised 678 stock options with an intrinsic value of $3,210, resulting in the cash proceeds to the Company of $942. As of March 31, 2023, the unrecognized stock-based compensation expense related to unvested stock options, was $19,961,367 and the estimated weighted average remaining vesting period was 2.6 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 months ended March 31, 2023, the Company did not record any stock-based compensation expense related to these PSUs on the basis that they still 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 | 3 Months Ended |
Mar. 31, 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. 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 March 31, 2023, the Company is committed to aggregate future payments of approximately $22.4 million in connection with these agreements. During the three months ended March 31, 2023 and March 31, 2022, approximately $2.9 million and $0.6 million, respectively, has been recorded within property, plant and equipment in connection with these agreements. 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 product 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. Minimum purchase commitments under these agreements include individual commitments up to $1.7 million. Aggregate remaining minimum commitments amount to approximately $3.6 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 product in the amount of approximately $109.5 million ($148.3 million CAD) over the contract term. The purchase commitments are contingent upon the completion of certain milestones by the third-party suppliers. The Company recorded $nil in connection with these agreements during the three months ended March 31, 2023 (three months ended March 31, 2022 - $nil). 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 10 year contract term. 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. The remaining minimum purchase commitment under this agreement is approximately $23.4 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 of the Company’s license agreements, see Note 15 in 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 is expanded to include all geographies worldwide and the Company will have increased flexibility in connection with sublicense arrangements. In consideration, the Company will make a payment of € 2.15 million as well as minimum annual licenses fees ranging from € 10-50 thousand. The Company is also obligated to make an additional milestone payment to Scintomics of €5 million upon the achievement of a specified regulatory milestone. See Note 15. The Company recorded research and development expenses in connection to its license agreements of approximately $0.5 million during the three months ended March 31, 2023 (three months ended March 31, 2022 – $0.8 million). |
Net loss per share
Net loss per share | 3 Months Ended |
Mar. 31, 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 March 31, 2023 Three months ended March 31, 2022 Net loss attributable to common stockholders $ 16,530,671 $ 16,380,574 Weighted-average common shares outstanding-basic and diluted 105,660,655 90,122,269 Net loss per share attributable to common stockholders-basic and diluted $ 0.16 $ 0.18 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 performance share units are considered contingently issuable shares for the purpose of the computation of loss per share and have been excluded on the basis that as at March 31, 2023, the performance condition for vesting had not been achieved. Therefore, the weighted-average number of shares of Common Stock outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the same. |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The Company calculates its interim tax provision, at the end of each interim period, the Company estimates the annual effective tax rate and applies that 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, as such it is subject to tax in both countries. The income tax expense for the three months ended March 31, 2023 and March 31, 2022 was $(238,642) and $88,116 respectively. The income tax benefit for the three months ended March 31, 2023, consists primarily of tax benefit for research and development tax credits partially offset by current taxes in Canada. The income tax benefit for the three months ended March 31, 2022, consists of current taxes in Canada. The Company files income tax returns in the U.S. federal, certain state, 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 March 31, 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 | 3 Months Ended |
Mar. 31, 2023 | |
Related Party Transactions [Abstract] | |
Schedule of 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 March 31, 2023 Three months ended March 31, 2022 Consulting fees on business activities to Board member $ 174,415 $ 66,696 Reimbursement to Board member for occupancy costs 17,419 17,778 Total $ 191,834 $ 84,474 Transactions with related parties are in the normal course of operations and have been measured at their agreed upon exchange amount. During the three-month periods ended March 31, 2023 and 2022, the Company received consulting services for research and development from a Board member. As of March 31, 2023, $107,650 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 Topic 842, Leases to this arrangement and is recording the lease payments of approximately $6,000 monthly as rent expense. |
Subsequent events
Subsequent events | 3 Months Ended |
Mar. 31, 2023 | |
Subsequent Events [Abstract] | |
Subsequent events | Subsequent events License Agreement Amendments On April 17, 2023, POINT Biopharma Inc. entered into the Amendments to that certain sublicense agreement, dated November 14, 2019, between POINT Biopharma Inc. and Scintomics. Pursuant to the Amendments, the exclusive, sublicensable, license is expanded to include all geographies worldwide and the Company will have increased flexibility in connection with sublicense arrangements. In consideration, the Company will make a payment of € 2.15 million as well as minimum annual licenses fees ranging from € 10-50 thousand. The Company is also obligated to make an additional milestone payment to Scintomics of €5 million upon the achievement of a specified regulatory milestone. Convertible Note 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. Pursuant to the Convertible Note Agreement, upon execution and subject to certain closing conditions, the Company will purchase $10 million in unsecured promissory notes convertible into common stock of Ionetix-α at a conversion price that is subject to certain conditions as defined in the Convertible Note Agreement. Supply Agreement On May 10, 2023, the Company entered into the Irradiation Agreement, pursuant to which the Company will receive irradiation services to irradiate 176 Yb. See Note 11. |
Summary of significant accoun_2
Summary of significant accounting policies (Policies) | 3 Months Ended |
Mar. 31, 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, 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 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 years ended December 31, 2022 and 2021, 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 Prior to the Lantheus License Agreements (as defined in Note 3 below), the Company had incurred significant net losses and had funded operations primarily through equity financings. Operating losses and negative cash flows were incurred in the quarter ended March 31, 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 the COVID-19 coronavirus, the Russo-Ukrainian conflict 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. |
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 to the performance obligations under the Lantheus License Agreements, the accrual of research and development expenses and the valuations of stock options. 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 experience. Changes in estimates are recorded in the period in which they become known. Actual results may differ from those estimates or assumptions. |
Recent accounting pronouncements | Recent accounting pronouncements The Company has evaluated accounting pronouncements recently issued but not yet adopted and believes that the current 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) | 3 Months Ended |
Mar. 31, 2023 | |
Revenue from Contract with Customer [Abstract] | |
Schedule of Contract Liabilities | The following table presents the Company’s contract liabilities as of March 31, 2023 and December 31, 2022 : March 31, 2023 December 31, 2022 Deferred revenue Deferred revenue, current $ 16,518,934 $ 23,242,290 Deferred revenue, net of current portion 7,444,239 10,178,147 Total $ 23,963,173 $ 33,420,437 |
Cash, cash equivalents and in_2
Cash, cash equivalents and investments (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Cash and Cash Equivalents [Abstract] | |
Schedule of Cash, Cash Equivalents and Investments | Cash, cash equivalents and investments consisted of the following: As of March 31, 2023 As of December 31, 2022 Cash $ 19,393,396 $ 12,429,627 Cash equivalents: Money market funds 91,746,221 273,998,744 Total cash and cash equivalents 111,139,617 286,428,371 Short-term investments Commercial paper 159,747,972 115,156,455 Corporate bonds 67,096,233 45,219,042 U.S. Government agency debt securities 58,250,793 42,577,762 Asset backed securities 33,798,585 35,830,211 Total short-term investments 318,893,583 238,783,470 Long-term investments Asset backed securities 48,352,696 16,119,430 Corporate bonds 40,817,639 — Total long-term investments 89,170,335 16,119,430 Total cash, cash equivalents and investments $ 519,203,535 $ 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 March 31, 2023 were as follows: Amortized Cost Unrealized Gains Unrealized Losses Fair Value Current Non-current Commercial paper $ 159,747,972 $ — $ — $ 159,747,972 $ 159,747,972 $ — Corporate bonds 108,167,585 15,551 $ (269,264) 107,913,872 67,096,233 40,817,639 Asset backed securities 82,135,898 74,656 (59,273) 82,151,281 33,798,585 48,352,696 U.S. Government agency debt securities 58,268,020 27,511 (44,738) 58,250,793 58,250,793 — Total available-for-sale securities $ 408,319,475 $ 117,718 $ (373,275) $ 408,063,918 $ 318,893,583 $ 89,170,335 The following table summarizes the fair value of available-for-sale investments based on stated contractual maturities as of March 31, 2023: Amortized Cost Fair Value Due within one year $ 319,134,902 $ 318,893,583 Due between one and five years 89,184,573 89,170,335 Total $ 408,319,475 $ 408,063,918 |
Fair value measurements (Tables
Fair value measurements (Tables) | 3 Months Ended |
Mar. 31, 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 March 31, 2023 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 (in thousands): Level 1 Level 2 Level 3 Total March 31, 2023 Cash equivalents: Money market mutual fund $ 91,746,221 $ — $ — $ 91,746,221 Available-for-sale debt securities: Commercial paper — 159,747,972 — 159,747,972 Corporate bonds — 107,913,872 — 107,913,872 Asset backed securities — 82,151,281 — 82,151,281 U.S. Government agency debt securities 58,250,793 — — 58,250,793 Total $ 149,997,014 $ 349,813,125 $ — $ 499,810,139 |
Prepaid expenses and other cu_2
Prepaid expenses and other current assets (Tables) | 3 Months Ended |
Mar. 31, 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 March 31, 2023 As of December 31, 2022 $ $ Prepaid clinical trial expenses 3,339,239 4,011,419 Prepaid insurance 859,141 1,310,314 Canadian harmonized sales tax receivable 159,045 60,222 Other 189,282 228,934 Total 4,546,707 5,610,889 |
Property, plant and equipment_2
Property, plant and equipment, net (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Summary of Property, Plant and Equipment, Net | Property, plant and equipment, net consisted of the following: As of March 31, 2023 As of December 31, 2022 $ $ Land and building 18,451,207 18,163,962 Machinery and equipment 9,015,960 5,328,639 Property, plant and equipment, in development 8,367,969 8,434,384 Furniture and fixtures 721,595 698,728 Computer equipment 149,892 149,892 36,706,623 32,775,605 Less: Accumulated depreciation (1,932,656) (1,395,029) Total 34,773,967 31,380,576 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 Building 20 years |
Accrued expenses (Tables)
Accrued expenses (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Accrued Liabilities, Current [Abstract] | |
Summary of Accrued Liabilities | Accrued liabilities consisted of the following: As of March 31, 2023 As of December 31, 2022 $ $ Accrued personnel costs 7,660,395 7,116,382 Accrued research and development costs 7,174,563 9,645,594 Accrued corporate legal fees and other professional services 1,536,575 2,068,793 Accrued costs for purchases of property, plant and equipment 41,236 105,741 Other accrued costs 202,297 157,944 Total 16,615,066 19,094,454 |
Stock-based compensation (Table
Stock-based compensation (Tables) | 3 Months Ended |
Mar. 31, 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 2,839,823 6.78 Exercised (32,936) 4.43 Forfeited (33,693) 8.25 Expired (9,546) 8.47 Outstanding as of March 31, 2023 8,355,821 6.16 4.8 Vested and expected to vest as of March 31, 2023 8,355,821 6.16 4.8 Options exercisable as of March 31, 2023 2,635,805 4.61 4.7 |
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 March 31, 2023 Three months ended March 31, 2022 Risk-free interest rate 3.71% 1.24% - 2.51% Expected term (in years) 4.25 4.25 Expected volatility 68% 72% - 73% Expected dividend yield — — |
Net loss per share (Tables)
Net loss per share (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Earnings Per Share [Abstract] | |
Summary of Basic and Diluted Net Loss per Share | Three months ended March 31, 2023 Three months ended March 31, 2022 Net loss attributable to common stockholders $ 16,530,671 $ 16,380,574 Weighted-average common shares outstanding-basic and diluted 105,660,655 90,122,269 Net loss per share attributable to common stockholders-basic and diluted $ 0.16 $ 0.18 |
Related party transaction (Tabl
Related party transaction (Tables) | 3 Months Ended |
Mar. 31, 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 March 31, 2023 Three months ended March 31, 2022 Consulting fees on business activities to Board member $ 174,415 $ 66,696 Reimbursement to Board member for occupancy costs 17,419 17,778 Total $ 191,834 $ 84,474 |
Nature of business - Narrative
Nature of business - Narrative (Details) | 3 Months Ended |
Mar. 31, 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 | 12 Months Ended | |
Dec. 31, 2022 | Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Revenue Recognition, Milestone Method [Line Items] | ||||
Revenue recognized for future performance | $ 34.8 | |||
Revenue recognized | $ 9.5 | $ 0 | ||
Lantheus Holdings, Inc. | License Agreements, PNT2002 Agreement | ||||
Revenue Recognition, Milestone Method [Line Items] | ||||
Upfront payment | $ 250 | |||
Milestone payment | $ 250 | |||
Royalty rate | 20% | 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% | 15% | ||
Annual net sales milestone payment | $ 275 |
Revenue - Contract Liabilities
Revenue - Contract Liabilities (Details) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Revenue from Contract with Customer [Abstract] | ||
Deferred revenue, current | $ 16,518,934 | $ 23,242,290 |
Deferred revenue, net of current portion | 7,444,239 | 10,178,147 |
Total | $ 23,963,173 | $ 33,420,437 |
Cash, cash equivalents and in_3
Cash, cash equivalents and investments - Schedule of cash, cash equivalents, and investments (Details) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Cash and Cash Equivalents [Line Items] | ||
Cash | $ 19,393,396 | $ 12,429,627 |
Money market funds | 91,746,221 | 273,998,744 |
Total cash and cash equivalents | 111,139,617 | 286,428,371 |
Short-term investments | 318,893,583 | 238,783,470 |
Long-term investments | 89,170,335 | 16,119,430 |
Total cash, cash equivalents and investments | 519,203,535 | 541,331,271 |
Commercial paper | ||
Cash and Cash Equivalents [Line Items] | ||
Short-term investments | 159,747,972 | 115,156,455 |
Corporate bonds | ||
Cash and Cash Equivalents [Line Items] | ||
Short-term investments | 67,096,233 | 45,219,042 |
Long-term investments | 40,817,639 | 0 |
U.S. Government agency debt securities | ||
Cash and Cash Equivalents [Line Items] | ||
Short-term investments | 58,250,793 | 42,577,762 |
Asset backed securities | ||
Cash and Cash Equivalents [Line Items] | ||
Short-term investments | 33,798,585 | 35,830,211 |
Long-term investments | $ 48,352,696 | $ 16,119,430 |
Cash, cash equivalents and in_4
Cash, cash equivalents and investments - Schedule of available-for-sale investments (Details) | Mar. 31, 2023 USD ($) |
Debt Securities, Available-for-sale [Line Items] | |
Amortized Cost | $ 408,319,475 |
Unrealized Gains | 117,718 |
Unrealized Losses | (373,275) |
Fair Value | 408,063,918 |
Current | 318,893,583 |
Non-current | 89,170,335 |
Commercial paper | |
Debt Securities, Available-for-sale [Line Items] | |
Amortized Cost | 159,747,972 |
Unrealized Gains | 0 |
Unrealized Losses | 0 |
Fair Value | 159,747,972 |
Current | 159,747,972 |
Non-current | 0 |
Corporate bonds | |
Debt Securities, Available-for-sale [Line Items] | |
Amortized Cost | 108,167,585 |
Unrealized Gains | 15,551 |
Unrealized Losses | (269,264) |
Fair Value | 107,913,872 |
Current | 67,096,233 |
Non-current | 40,817,639 |
U.S. Government agency debt securities | |
Debt Securities, Available-for-sale [Line Items] | |
Amortized Cost | 58,268,020 |
Unrealized Gains | 27,511 |
Unrealized Losses | (44,738) |
Fair Value | 58,250,793 |
Current | 58,250,793 |
Non-current | 0 |
Asset backed securities | |
Debt Securities, Available-for-sale [Line Items] | |
Amortized Cost | 82,135,898 |
Unrealized Gains | 74,656 |
Unrealized Losses | (59,273) |
Fair Value | 82,151,281 |
Current | 33,798,585 |
Non-current | $ 48,352,696 |
Cash, cash equivalents and in_5
Cash, cash equivalents and investments - Schedule of available-for-sale investments by maturity (Details) | Mar. 31, 2023 USD ($) |
Amortized Cost | |
Due within one year | $ 319,134,902 |
Due between one and five years | 89,184,573 |
Amortized Cost | 408,319,475 |
Fair Value | |
Due within one year | 318,893,583 |
Due between one and five years | 89,170,335 |
Fair Value | $ 408,063,918 |
Cash, cash equivalents and in_6
Cash, cash equivalents and investments - Narrative (Details) | 3 Months Ended |
Mar. 31, 2023 USD ($) | |
Cash and Cash Equivalents [Abstract] | |
Realized gain (loss) on available-for-sale debt investments | $ 0 |
Fair value measurements - Sched
Fair value measurements - Schedule of financial assets and liabilities measured at fair value on a recurring basis (Details) | Mar. 31, 2023 USD ($) |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Available-for-sale debt securities: | $ 408,063,918 |
Fair Value, Recurring | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Total | 499,810,139 |
Fair Value, Recurring | Level 1 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Total | 149,997,014 |
Fair Value, Recurring | Level 2 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Total | 349,813,125 |
Fair Value, Recurring | Level 3 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Total | 0 |
Commercial paper | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Available-for-sale debt securities: | 159,747,972 |
Commercial paper | Fair Value, Recurring | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Available-for-sale debt securities: | 159,747,972 |
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 |
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: | 159,747,972 |
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 |
Corporate bonds | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Available-for-sale debt securities: | 107,913,872 |
Corporate bonds | Fair Value, Recurring | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Available-for-sale debt securities: | 107,913,872 |
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 |
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: | 107,913,872 |
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 |
Asset backed securities | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Available-for-sale debt securities: | 82,151,281 |
Asset backed securities | Fair Value, Recurring | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Available-for-sale debt securities: | 82,151,281 |
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 |
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: | 82,151,281 |
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 |
U.S. Government agency debt securities | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Available-for-sale debt securities: | 58,250,793 |
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: | 58,250,793 |
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: | 58,250,793 |
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 |
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 |
Money market mutual fund | Fair Value, Recurring | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Cash equivalents: | 91,746,221 |
Money market mutual fund | Fair Value, Recurring | Level 1 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Cash equivalents: | 91,746,221 |
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 |
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 |
Prepaid expenses and other cu_3
Prepaid expenses and other current assets (Details) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Prepaid Expense and Other Assets, Current [Abstract] | ||
Prepaid clinical trial expenses | $ 3,339,239 | $ 4,011,419 |
Prepaid insurance | 859,141 | 1,310,314 |
Canadian harmonized sales tax receivable | 159,045 | 60,222 |
Other | 189,282 | 228,934 |
Total | $ 4,546,707 | $ 5,610,889 |
Property, plant and equipment_3
Property, plant and equipment, net (Details) | Mar. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | Jul. 10, 2020 ft² |
Property, Plant and Equipment [Line Items] | |||
Property, plant and equipment, gross | $ 36,706,623 | $ 32,775,605 | |
Less: Accumulated depreciation | (1,932,656) | (1,395,029) | |
Total | 34,773,967 | 31,380,576 | |
Square-foot of building | ft² | 81,000 | ||
Land and building | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant and equipment, gross | 18,451,207 | 18,163,962 | |
Machinery and equipment | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant and equipment, gross | 9,015,960 | 5,328,639 | |
Property, plant and equipment, in development | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant and equipment, gross | 8,367,969 | 8,434,384 | |
Furniture and fixtures | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant and equipment, gross | 721,595 | 698,728 | |
Computer equipment | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant and equipment, gross | $ 149,892 | $ 149,892 |
Property, plant and equipment_4
Property, plant and equipment, net - Estimated Useful Life (Details) | 3 Months Ended |
Mar. 31, 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 |
Building | |
Property, Plant and Equipment [Line Items] | |
Estimated Useful Life | 20 years |
Accrued expenses (Details)
Accrued expenses (Details) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Accrued Liabilities, Current [Abstract] | ||
Accrued personnel costs | $ 7,660,395 | $ 7,116,382 |
Accrued research and development costs | 7,174,563 | 9,645,594 |
Accrued corporate legal fees and other professional services | 1,536,575 | 2,068,793 |
Accrued costs for purchases of property, plant and equipment | 41,236 | 105,741 |
Other accrued costs | 202,297 | 157,944 |
Total | $ 16,615,066 | $ 19,094,454 |
Stockholders' equity (Details)
Stockholders' equity (Details) | 3 Months Ended | |||
Mar. 31, 2023 USD ($) vote $ / shares shares | Mar. 31, 2022 USD ($) 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 | ||
Common shares, par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | ||
Common stock, shares issued (in shares) | 105,682,677 | 105,649,741 | ||
Common stock, shares outstanding (in shares) | 105,682,677 | 105,649,741 | ||
Preferred stock, shares outstanding (in shares) | 0 | 0 | ||
Preferred stock, shares Issued (in shares) | 0 | 0 | ||
Number of votes per share | vote | 1 | |||
Cash dividend declared | $ | $ 0 | $ 0 | ||
Cash dividend paid | $ | 0 | 0 | ||
Non-employee consultant | ||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||
Issuance of shares of Common Stock | $ | 20,850 | $ 942 | ||
Board member | ||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||
Issuance of shares of Common Stock | $ | $ 125,014 | |||
Preferred shares | ||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||
Preferred shares, shares authorized (in shares) | 20,000,000 | |||
Preferred stock, par value (in dollars per share) | $ / shares | $ 0.0001 | |||
Issuance of shares of Common Stock, net of direct and incremental costs (in shares) | 0 | |||
Common Stock | ||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||
Issuance of shares of Common Stock in connection with stock option exercises (in shares) | 32,936 | 678 | ||
Common stock, shares outstanding (in shares) | 105,682,677 | 90,122,472 | 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) | 15,000 | |||
Issuance of shares of Common Stock | $ | $ 20,850 | $ 942 | ||
Issuance of shares of Common Stock, net of direct and incremental costs in connection with the Business Combination (refer to Note 3) (in shares) | 678 | |||
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) | 17,936 | |||
Issuance of shares of Common Stock | $ | $ 125,014 |
Stock-based compensation - Narr
Stock-based compensation - Narrative (Details) - USD ($) | 3 Months Ended | 12 Months Ended | ||
Jan. 01, 2022 | Mar. 31, 2023 | Mar. 31, 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 authorized for issuance under plan (in shares) | 4,225,990 | |||
Number of shares authorized for issuance under plan (in shares) | 9,344,912 | |||
Unrecognized stock-based compensation | $ 19,961,367 | |||
Period for recognition | 2 years 7 months 6 days | |||
Vesting on 1st year anniversary | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Vesting percentage | 25% | 25% | ||
Vesting ratably over the remaining three years | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Vesting percentage | 75% | 75% | ||
Non-employee consultant | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Proceeds from issuance of shares of common stock | $ 20,850 | $ 942 | ||
Board member | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Proceeds from issuance of shares of common stock | $ 125,014 | |||
Stock options | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Number of options granted (in shares) | 2,839,823 | 1,705,197 | ||
Issuance of shares of Common Stock in connection with stock option exercises (in shares) | 32,936 | |||
Stock options | Vesting on 1st year anniversary | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Vesting period | 1 year | 1 year | ||
Stock options | Vesting ratably over the remaining three years | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Vesting period | 3 years | 3 years | ||
Stock options | Employee | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Options granted in period, weighted average grant date fair value (in dollars per share) | $ 3.76 | $ 4.58 | ||
Stock options | Non-employee consultant | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Issuance of shares of Common Stock in connection with stock option exercises (in shares) | 15,000 | 678 | ||
Intrinsic value | $ 95,450 | $ 3,210 | ||
Stock options | Board member | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Issuance of shares of Common Stock in connection with stock option exercises (in shares) | 17,936 | |||
Intrinsic value | $ 5,560 | |||
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 | 446,128 | 285,311 | ||
General and administrative | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based compensation expense | $ 563,368 | $ 155,139 |
Stock-based compensation - Summ
Stock-based compensation - Summarizes activity relating to options to purchase stock (Details) - Stock options - $ / shares | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Number of Shares | ||
Outstanding as of December 31, 2022 (in shares) | 5,592,173 | |
Granted (in shares) | 2,839,823 | 1,705,197 |
Exercised (in shares) | (32,936) | |
Forfeited (in shares) | (33,693) | |
Expired (in shares) | (9,546) | |
Outstanding as of March 31, 2023 (in shares) | 8,355,821 | |
Weighted Average Exercise Price $ | ||
Outstanding as of December 31, 2022 (in dollars per share) | $ 5.85 | |
Granted (in dollars per share) | 6.78 | |
Exercised (in dollars per share) | 4.43 | |
Forfeited (in dollars per share) | 8.25 | |
Expired (in dollars per share) | 8.47 | |
Outstanding as of March 31, 2023 (in dollars per share) | $ 6.16 | |
Weighted- Average Remaining Contractual Term (in years) | ||
Outstanding as of March 31, 2023 (in years) | 4 years 9 months 18 days | |
Vested and expected to vest as of March 31, 2023 (in shares) | 8,355,821 | |
Options exercisable as of March 31, 2023 (in shares) | 2,635,805 | |
Vested and expected to vest as of March 31, 2023 (in dollars per share) | $ 6.16 | |
Options exercisable as of March 31, 2023 (in dollars per share) | $ 4.61 | |
Vested and expected to vest as of March 31, 2023 (in years) | 4 years 9 months 18 days | |
Options exercisable as of March 31, 2023 (in years) | 4 years 8 months 12 days | |
Board member | ||
Number of Shares | ||
Exercised (in shares) | (17,936) |
Stock-based compensation - Assu
Stock-based compensation - Assumptions used in Black-Scholes-Merton option-pricing model (Details) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | ||
Risk-free interest rate | 3.71% | |
Risk-free interest rate, minimum | 0.0124% | |
Risk-free interest rate, maximum | 0.0251% | |
Expected term (in years) | 4 years 3 months | 4 years 3 months |
Expected volatility | 68% | |
Expected volatility, minimum | 0.72% | |
Expected volatility, maximum | 0.73% | |
Expected dividend yield | 0% | 0% |
Commitments and contingencies -
Commitments and contingencies - Property in development commitment (Details) - Property, in development commitment - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Other Commitments [Line Items] | ||
Future payments relating to the construction and retrofit of the building | $ 22.4 | |
Total aggregate remaining minimum commitment | $ 2.9 | $ 0.6 |
Commitments and contingencies_2
Commitments and contingencies - Clinical trial and commercial commitments & License agreements (Details) € in Thousands, $ in Millions | 3 Months Ended | ||||
May 10, 2023 USD ($) | Apr. 17, 2023 EUR (€) | Mar. 31, 2023 USD ($) | Mar. 31, 2023 CAD ($) | Mar. 31, 2022 USD ($) | |
Scintomics GMBH ("SCI") | License Agreement | Subsequent events. | |||||
Long-term Purchase Commitment [Line Items] | |||||
Collaborative arrangement payments made | € | € 2,150 | ||||
Scintomics GMBH ("SCI") | License Agreement | Subsequent events. | Specified development milestones | |||||
Long-term Purchase Commitment [Line Items] | |||||
Milestone payment | € | 5,000 | ||||
Research and development | License agreements | |||||
Long-term Purchase Commitment [Line Items] | |||||
Total aggregate remaining minimum commitment | $ 500,000 | $ 800,000 | |||
Supply agreements in connection with clinical trials | |||||
Long-term Purchase Commitment [Line Items] | |||||
Total aggregate remaining minimum commitment | 3,600,000 | ||||
Supply agreements in connection | Research and development | |||||
Long-term Purchase Commitment [Line Items] | |||||
Total aggregate remaining minimum commitment | 6,500,000 | 1,700,000 | |||
Supply agreement to purchase certain products | |||||
Long-term Purchase Commitment [Line Items] | |||||
Minimum purchase commitments | 109,500,000 | $ 148.3 | |||
Supply agreement to purchase certain products | Subsequent events. | |||||
Long-term Purchase Commitment [Line Items] | |||||
Minimum purchase commitments | $ 32,400,000 | ||||
Agreement in connection | |||||
Long-term Purchase Commitment [Line Items] | |||||
Total aggregate remaining minimum commitment | 0 | 0 | |||
Agreement in connection with the SPLASH clinical phase study | |||||
Long-term Purchase Commitment [Line Items] | |||||
Total aggregate remaining minimum commitment | 23,400,000 | ||||
Agreement in connection with the SPLASH clinical phase study | Research and development | |||||
Long-term Purchase Commitment [Line Items] | |||||
Total aggregate remaining minimum commitment | 4,900,000 | $ 3,100,000 | |||
Maximum | Scintomics GMBH ("SCI") | License Agreement | Subsequent events. | |||||
Long-term Purchase Commitment [Line Items] | |||||
License fee | € | 50 | ||||
Maximum | Supply agreements in connection with clinical trials | |||||
Long-term Purchase Commitment [Line Items] | |||||
Minimum purchase commitments | $ 1,700,000 | ||||
Term for total aggregate remaining minimum commitment | 8 years | 8 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 | Scintomics GMBH ("SCI") | License Agreement | Subsequent events. | |||||
Long-term Purchase Commitment [Line Items] | |||||
License fee | € | € 10 | ||||
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 | 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 | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Earnings Per Share [Abstract] | ||
Net loss attributable to common stockholders | $ 16,530,671 | $ 16,380,574 |
Weighted-average common shares outstanding - basic (in shares) | 105,660,655 | 90,122,269 |
Weighted-average common shares outstanding - diluted (in shares) | 105,660,655 | 90,122,269 |
Net loss per share attributable to common stockholders - basic (in dollars per share) | $ 0.16 | $ 0.18 |
Net loss per share attributable to common stockholders - diluted (in dollars per share) | $ 0.16 | $ 0.18 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Income Tax Disclosure [Abstract] | ||
Income tax expense | $ (238,642) | $ 88,116 |
Related party transactions - Sc
Related party transactions - Schedule of Related Party Transactions (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Related Party Transaction [Line Items] | ||
Related party expenses | $ 191,834 | $ 84,474 |
Consulting fees on business activities to Board member | ||
Related Party Transaction [Line Items] | ||
Related party expenses | 174,415 | 66,696 |
Reimbursement to Board member for occupancy costs | ||
Related Party Transaction [Line Items] | ||
Related party expenses | $ 17,419 | $ 17,778 |
Related party transactions -Nar
Related party transactions -Narrative (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Dec. 31, 2022 | |
Related Party Transaction [Line Items] | ||
Accrued liabilities | $ 16,615,066 | $ 19,094,454 |
Rent expense with related party | 6,000 | |
Director | ||
Related Party Transaction [Line Items] | ||
Accrued liabilities | $ 107,650 |
Subsequent events (Details)
Subsequent events (Details) - Subsequent events. € in Thousands, $ in Millions | Apr. 17, 2023 EUR (€) | May 07, 2023 USD ($) |
Convertible Debt | Convertible Note | ||
Subsequent Event [Line Items] | ||
Convertible notes | $ | $ 10 | |
Scintomics GMBH ("SCI") | License Agreement | ||
Subsequent Event [Line Items] | ||
Collaborative arrangement payments made | € 2,150 | |
Scintomics GMBH ("SCI") | License Agreement | Specified development milestones | ||
Subsequent Event [Line Items] | ||
Milestone payment | 5,000 | |
Scintomics GMBH ("SCI") | License Agreement | Minimum | ||
Subsequent Event [Line Items] | ||
License fee | 10 | |
Scintomics GMBH ("SCI") | License Agreement | Maximum | ||
Subsequent Event [Line Items] | ||
License fee | € 50 |