0001564590-22-006299 | 10-K | XBRL Viewer

Balance Sheets - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
Current assets
Cash and cash equivalents	$ 221,186	$ 207,306
Restricted cash	63	63
Accounts Receivable	5,688	237
Inventories	3,471
Prepaid expenses and other current assets	13,157	8,786
Total current assets	243,565	216,392
Property and equipment, net	2,013	2,482
Restricted cash	312	437
Operating lease assets	7,035	8,026
Other assets	1,169	1,215
Total assets	254,094	228,552
Current liabilities
Accounts payable	2,897	3,572
Accrued expenses	23,180	16,486
Deferred revenue	31	237
Other current liabilities	1,505	3,148
Total current liabilities	27,613	23,443
Loan payable	75,190	19,893
Deferred revenue	1,000
Operating lease liabilities	6,750	7,865
Total liabilities	110,553	51,201
Stockholders’ equity
Common stock, $0.0001 par value, 120,000,000 shares authorized as of December 31, 2021 and December 31, 2020, respectively; 42,588,814 and 38,140,756 shares issued as of December 31, 2021 and December 31, 2020, respectively; 42,562,148 and 38,114,090 shares outstanding as of December 31, 2021 and December 31, 2020, respectively	4	4
Treasury stock, 26,666 shares	(8)	(8)
Additional paid-in capital	728,004	613,462
Accumulated deficit	(584,459)	(436,107)
Total stockholders’ equity	143,541	177,351
Total liabilities and stockholders' equity	$ 254,094	$ 228,552

Balance Sheets (Parenthetical) - $ / shares	Dec. 31, 2021	Dec. 31, 2020
Statement Of Financial Position [Abstract]
Common stock, par value	$ 0.0001	$ 0.0001
Common stock, shares authorized	120,000,000	120,000,000
Common stock, shares, issued	42,588,814	38,140,756
Common stock, shares, outstanding	42,562,148	38,114,090
Treasury stock, shares	26,666	26,666

Statements of Operations - USD ($) $ in Thousands	12 Months Ended
Statements of Operations - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
Revenues:
Total revenues	$ 31,476	$ 45,285
Operating expenses:
Cost of goods sold	2,016
Research and development	76,225	73,271	$ 89,002
Selling, general and administrative	95,692	68,490	40,039
Total operating expenses	173,933	141,761	129,041
Loss from operations	(142,457)	(96,476)	(129,041)
Other income (expense):
Interest income	43	952	6,579
Interest expense	(4,667)	(1,778)
Other income (expense)	(346)	(542)	15
Total other income (expense), net	(4,970)	(1,368)	6,594
Loss before income taxes	(147,427)	(97,844)	(122,447)
Income tax expense	925	1,410
Net loss	$ (148,352)	$ (99,254)	$ (122,447)
Net loss per share, basic and diluted	$ (3.54)	$ (2.62)	$ (3.27)
Weighted average common shares outstanding, basic and diluted	41,943,417	37,878,026	37,499,256
Product Sales, Net
Revenues:
Total revenues	$ 11,120
License Revenue
Revenues:
Total revenues	$ 20,356	$ 45,285

Statements of Redeemable Convertible Preferred Stock and Stockholders' Equity (Deficit) - USD ($) $ in Thousands	Total	Common Stock	Treasury Stock	Additional Paid-in Capital	Accumulated Deficit
Balance at Dec. 31, 2018	$ 358,820	$ 4	$ (8)	$ 573,230	$ (214,406)
Balance (in shares) at Dec. 31, 2018		37,268,792	(26,666)
Exercise of common stock options	2,705			2,705
Exercise of common stock options (in shares)		369,468
Stock-based compensation	16,449			16,449
Net loss during year	(122,447)				(122,447)
Balance at Dec. 31, 2019	255,527	$ 4	$ (8)	592,384	(336,853)
Balance (in shares) at Dec. 31, 2019		37,638,260	(26,666)
Exercise of common stock options	2,308			2,308
Exercise of common stock options (in shares)		502,496
Stock-based compensation	18,770			18,770
Net loss during year	(99,254)				(99,254)
Balance at Dec. 31, 2020	177,351	$ 4	$ (8)	613,462	(436,107)
Balance (in shares) at Dec. 31, 2020		38,140,756	(26,666)
Public offering (ATM)	86,378			86,378
Public offering (ATM), shares		3,513,027
Exercise of common stock options	$ 5,845			5,845
Exercise of common stock options (in shares)	935,031	935,031
Stock-based compensation	$ 22,319			22,319
Net loss during year	(148,352)				(148,352)
Balance at Dec. 31, 2021	$ 143,541	$ 4	$ (8)	$ 728,004	$ (584,459)
Balance (in shares) at Dec. 31, 2021		42,588,814	(26,666)

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

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Statements of Cash Flows - USD ($) $ in Thousands	12 Months Ended
Statements of Cash Flows - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
Cash flows from operating activities
Net loss	$ (148,352)	$ (99,254)	$ (122,447)
Adjustments to reconcile net loss to net cash used in operating activities
Stock-based compensation	22,319	18,770	16,449
Depreciation and amortization	469	582	356
Loss on disposal of fixed assets		322
Amortization of debt issuance costs	1,113	615
Loss on extinguishment of debt	220
Non-cash interest expense	591	166
Non-cash equity interest, net	370	(867)
Change in operating assets and liabilities
Accounts Receivable	(5,451)	(237)
Inventories	(3,471)
Prepaid expenses and other assets	(3,380)	(5,545)	(219)
Accounts payable	(675)	(244)	248
Accrued expenses and other liabilities	3,345	1,713	6,042
Deferred revenue	794	237
Net cash used in operating activities	(132,108)	(83,742)	(99,571)
Cash flows from investing activities
Proceeds from disposal of property and equipment		152
Purchases of property and equipment			(2,716)
Net cash provided/used in investing activities		152	(2,716)
Cash flows from financing activities
Proceeds from stock options exercised	5,845	2,308	2,705
Proceeds from loan agreement	55,000	20,000
Payments of debt issuance costs	(1,360)	(620)
Proceeds from public offering, net of underwriting fees and commissions	86,429
Payment of public offering costs	(51)
Net cash provided by financing activities	145,863	21,688	2,705
Net change in cash, cash equivalents and restricted cash	13,755	(61,902)	(99,582)
Cash, cash equivalents and restricted cash
Beginning of period	207,806	269,708	369,290
End of period	221,561	207,806	269,708
Supplemental disclosure of cash flow information
Cash paid for interest	$ 2,908	997
Non-cash investing and financing activities
Upfront project costs and other current assets in accounts payable and accrued expenses		$ 132	43
Purchases of equipment in accounts payable and accrued expenses			41
Operating lease liabilities arising from obtaining right-of-use asset			$ 8,947

Description of Business

12 Months Ended

Dec. 31, 2021

Organization Consolidation And Presentation Of Financial Statements [Abstract]

Description of Business

1. Description of Business

G1 Therapeutics, Inc. (the “Company”) is a commercial-stage biopharmaceutical company based in Research Triangle Park, North Carolina focused on the development and commercialization of novel small molecule therapeutics for the treatment of patients with cancer. The Company’s first FDA-approved product, COSELA™ (trilaciclib) is the first and only therapy indicated to proactively help protect bone marrow from the damage of chemotherapy and is first innovation in managing myelosuppression in decades. The Company was incorporated on May 19, 2008 in the state of Delaware.

The Company uses “COSELA” when referring to its FDA approved drug and “trilaciclib” when referring to the development of COSELA for additional indications.

The Company is advancing trilaciclib, a first-in-class therapy designed to improve outcomes for patients who are treated with chemotherapy, in clinical trials assessing myeloprotection and anti-tumor efficacy endpoints in a variety of tumors including colorectal cancer (“CRC”), breast cancer, bladder cancer, and in trials designed to inform the design of future additional pivotal studies across multiple tumor types and treatment combinations including targeted chemotherapy medicines called antibody-drug conjugates (“ADCs”).

The Company’s clinical approach to designing our clinical program includes monitoring the evolution of future standards of care and develop trilaciclib with these in mind, allowing it to conduct or support trials that will generate important data to maximize future usage in a variety of future settings. The Company’s robust clinical pipeline includes the following ongoing trials:

•

Phase 3 trial in colorectal cancer (initial results including myeloprotection and ORR endpoints expected in 1Q2023)

•

Phase 3 trial in 1L mTNBC (initial results including interim results for OS expected in 2H2023

•

Phase 2 trial in bladder cancer (initial results including ORR and myeloprotection endpoints expected in 4Q2022)

•

Phase 2 trial in combination with the ADC Trodelvy (initial results including ORR and myeloprotection endpoints expected in 4Q2022)

•

Phase 2 trial to confirm the immune-based mechanism of action (MOA) of trilaciclib in early-stage neoadjuvant TNBC (initial results including immune endpoints (e.g., CD8+ / Treg ratio) expected in 4Q2022)

The Company is also conducting extensive preclinical development work to assess the synergistic potential of trilaciclib with a variety of new anti-cancer mechanisms.

The Company also has a robust Investigator Initiated Studies (“ISS”) program. An ISS is a study that is developed and conducted by a qualified physician external to the Company who assumes full responsibility for the conduct of the study. The Company supports investigator sponsored studies that align with its areas of scientific interest. The Company anticipates that the first ISS to be supported by G1 will be in 1L NSCLC and expect it to be initiated in the first half of 2022.

The Company out-licensed global rights to lerociclib, an internally discovered and differentiated oral CDK4/6 inhibitor designed to enable more effective combination treatment strategies across multiple oncology indications. In addition, the company out-licensed global rights to an internally discovered CDK2 inhibitor for all human and veterinary uses. The Company is in the process of evaluating partnering options for rintodestrant, an oral selective estrogen receptor degrader (SERD) for the potential treatment of ER+, HER2- breast cancer. The Company also has intellectual property focused on cyclin-dependent kinase targets.

Trilaciclib

The Company’s lead compound, COSELA™ (trilaciclib), is a first-in-class therapy approved to help protect hematopoietic stem and progenitor cells (“HSPCs”) in bone marrow against chemotherapy-induced myelosuppression by transiently inhibiting CDK4/6 in patients with extensive-stage small cell lunger cancer (“ES-SCLC”). This action leads to temporary arrest of susceptible host cells during chemotherapy. This reduces the duration and severity of neutropenia and other myelosuppressive consequences of chemotherapy.

Trilaciclib is a novel therapeutic approach, which is given before chemotherapy, that temporarily blocks progression through the cell cycle. Its short half-life and IV route of administration allows for rapid onset, controlled administration, and clean G1 arrest, which are important attributes required for its unique mechanism of action. Transient IV CDK4/6 inhibition with trilaciclib provides two benefits. First, it proactively helps protect HSPCs in bone marrow leading to preservation of neutrophils, erythrocytes, and platelets (called myeloprotection) which reduces the occurrences and severity of neutropenia and other myelosuppressive consequences of chemotherapy. This myeloprotection benefit has been conclusively proven in double-blind placebo-controlled clinical trials in

extensive-stage small cell lung cancer. Second, clinical data has shown that trilaciclib has the potential to activate and enhance the immune system response driving increased anti-tumor efficacy, which we are exploring in clinical trials in a variety of solid tumor types and treatment settings.

On February 12, 2021, COSELA (trilaciclib) for injection was approved by the U.S. Food and Drug Administration (“FDA”) to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for ES-SCLC. On March 2, 2021, COSELA became commercially available through the Company’s specialty distributor network. COSELA is administered intravenously as a 30-minute infusion completed within four (4) hours prior to the start of chemotherapy and is the first FDA-approved therapy to provide proactive, multilineage protection from chemotherapy-induced myelosuppression. The approval of COSELA is based on data from three (3) randomized, placebo-controlled trials that showed patients receiving COSELA prior to chemotherapy had clinically meaningful and statistically significant reduction in the duration and severity of neutropenia, reduction of red blood cell transfusions, as well as improvements in other myeloprotection measures, compared to patients receiving chemotherapy without COSELA. The Company announced on March 25, 2021 that COSELA had been included in two updated National Comprehensive Cancer Network® (“NCCN”) Clinical Practice Guidelines in Oncology (NCCN Guidelines®): The Treatment Guidelines for Small Cell Lung Cancer and the Supportive Care Guidelines for Hematopoietic Growth Factors. These guidelines document evidence-based, consensus-driven management to ensure that all patients receive preventive, diagnostic, treatment, and supportive services that are most likely to lead to optimal outcomes. On October 1, 2021, the Company announced that the permanent J-code for COSELA that was issued in July 2021 by the Centers for Medicare & Medicaid Services (CMS) is now effective for provider billing for all sites of care. All hospital outpatient departments, ambulatory surgery centers and physician offices in the United States have one consistent Healthcare Common Procedure Coding System (HCPCS) code to standardize the submission and payment of COSELA insurance claims across Medicare, Medicare Advantage, Medicaid and commercial plans. G1’s new technology add-on payment (NTAP) for COSELA which provides additional payment to inpatient hospitals above the standard Medicare Severity Diagnosis-Related Group (MS-DRG) payment amount also became effective for provider billing on October 1, 2021.

In June 2020, we entered into a three-year co-promotion agreement for COSELA in the United States and Puerto Rico with Boehringer Ingelheim Pharmaceuticals, Inc. (“BI”). In December 2021, G1 and BI mutually agreed to end the co-promotion agreement for COSELA, effective March 2022. At that time, the Company announced that it would hire and deploy a total of 34 oncology sales representatives to allow G1 to target all accounts to accelerate sales activities and help maximize the adoption of COSELA. As of February 21, 2022, all 34 sales representatives have been hired, trained and deployed.

In August 2020, the Company entered into an exclusive license agreement with Nanjing Simcere Dongyuan Pharmaceutical Co., Ltd (“Simcere”) for development and commercialization rights for trilaciclib in all indications in Greater China (mainland China, Hong Kong, Macau and Taiwan). Under the terms of the agreement, the Company received an upfront payment of $14.0 million in September 2020 and will be eligible to receive up to $156.0 million in development and commercial milestone payments. During the twelve months ended December 31, 2021, the Company received three development milestone payments totaling $8.0 million. Simcere will also pay the Company tiered low double-digit royalties on annual net sales of trilaciclib in Greater China. As part of this agreement, Simcere will participate in global clinical trials of trilaciclib and the companies will be responsible for all development and commercialization costs in their respective territories.

The Company is also executing on our tumor-agnostic strategy to evaluate the potential benefits of trilaciclib to patients with other tumors and to continuously develop new data with trilaciclib in a variety of chemotherapeutic settings and in combination with other agents to maximize the applicability of the drug to potential future treatment paradigms.

Lerociclib

Lerociclib is a differentiated clinical-stage oral CDK4/6 inhibitor for use in combination with other targeted therapies in multiple oncology indications. In 2020, the Company entered into separate, exclusive agreements with EQRx, Inc. (rights for U.S., Europe, Japan and all markets outside Asia-Pacific) and Genor Biopharma Co. Inc. (rights for Asia-Pacific, excluding Japan) for the development and commercialization of lerociclib in all indications. Combined, these agreements provide $26.0 million in upfront payments to the Company, and the opportunity for up to $330.0 million in potential milestone payments, plus sales-based royalties. EQRx, Inc. and Genor Biopharma Co. Inc. are responsible for all costs related to the development and commercialization of lerociclib in their respective territories.

Rintodestrant

Rintodestrant is an oral SERD for the treatment of estrogen receptor-positive (“ER+”) breast cancer. The Company is in the process of evaluating partnering options for rintodestrant.

CDK2 Inhibitor

In 2020, we entered into a global license agreement with ARC Therapeutics, LLC for the development and commercialization of an internally discovered CDK2 inhibitor for all human and veterinary uses. ARC is currently granted an exclusive, royalty-bearing, license with the right to grant sublicenses to one of our solely owned patent families.

The Company’s financial statements have been prepared assuming 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. As of December 31, 2021, the Company had an accumulated deficit of $584.5 million. The Company has reported a net loss in all fiscal periods since inception and expects to incur substantial losses in the future to conduct research and development and pre-commercialization activities.

As of December 31, 2021, the Company had cash and cash equivalents of $221.2 million. The Company expects that its existing cash and cash equivalents will enable it to fund its operating expenses and capital expenditure requirements for greater than 12 months from the date of filing this Annual Report.

Basis of Presentation and Summary of Significant Accounting Policies

12 Months Ended

Dec. 31, 2021

Accounting Policies [Abstract]

Basis of Presentation and Summary of Significant Accounting Policies

2. Basis of Presentation and Summary of Significant Accounting Policies

Basis of Presentation

The Company has prepared the accompanying financial statements in conformity with generally accepted accounting principles in the United States of America (“U.S. GAAP”).

Use of Estimates

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and the accompanying notes. On an ongoing basis, the Company’s management evaluates its estimates which include, but are not limited to, estimates related to accrued expenses, accrued external clinical costs, net product sales, stock-based compensation expense and deferred tax asset valuation allowance. Actual results could differ from those estimates. These estimates include the Company’s common stock valuation, stock compensation, and deferred tax asset valuation allowance.

Accounts Receivable

The Company’s accounts receivable consists of amounts due from specialty distributors in the U.S. (collectively, its “Customers”) related to sales of COSELA and have standard payment terms. Trade receivables are recorded net of the estimated variable consideration for chargebacks based on contractual terms and the Company’s expectation regarding the utilization and earnings of the chargebacks and discounts as well as the net amount expected to be collected from the Company’s customers. Estimates of the Company’s credit losses are determined based on existing contractual payment terms, individual customer circumstances, and any changes to the economic environment.

In addition, the Company’s accounts receivable consists of open invoices issued to its license partners for services rendered by the Company or receivables with its license partners for invoices related to milestones that were completed and recognized as revenue.

Inventories

Inventories are stated at the lower of cost or net realizable value and recognized on a weighted-average cost method. The Company uses actual cost to determine the cost basis for inventory. Inventory is capitalized based on when future economic benefit is expected to be realized. Due to the nature of the Company’s supply chain process, inventory that is owned by the Company, is physically stored at third-party warehouses, logistics providers, and contract manufacturers. The Company began capitalizing inventory upon receiving FDA approval for COSELA on February 12, 2021. Prior to FDA approval of COSELA, expenses associated with the manufacturing of the Company's products were recorded as research and development expense.

Inventory valuation is established based on a number of factors including, but not limited to, finished goods not meeting product specifications, product excess and obsolescence, or application of the lower of cost or net realizable value concepts. The determination of events requiring the establishment of inventory valuation, together with the calculation of the amount of such adjustments may require judgment. The Company analyzes its inventory levels on a periodic basis to determine if any inventory is at risk for expiration prior to sale or has a cost basis that is greater than its estimated future net realizable value. Any adjustments are recognized through

cost of sales in the period in which they are incurred. No inventory valuation adjustments have been recorded for any periods presented.

Revenue Recognition

For elements of those arrangements that we determine should be accounted for under ASC 606, Revenue from Contracts with Customers (“ASC 606”), we assess which activities in our license or collaboration agreements are performance obligations that should be accounted for separately and determine the transaction price of the arrangement, which includes the assessment of the probability of achievement of future milestones and other potential consideration. For arrangements that include multiple performance obligations, such as granting a license or performing manufacturing or research and development activities, we allocate the transaction price based on the relative standalone selling price and recognize revenue that is allocated to the respective performance obligation when (or as) control is transferred to the customer and the performance obligation is satisfied. Accordingly, we develop assumptions that require judgment to determine the standalone selling price for each performance obligation identified in the contract. These key assumptions may include revenue forecasts, clinical development timelines and costs, discount rates and probabilities of clinical and regulatory success.

Licenses of Intellectual Property

If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue associated with the bundled performance obligation. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of progress and related revenue recognition.

Milestone Payments

At the inception of each arrangement that includes developmental and regulatory milestone payments, the Company evaluates whether the achievement of each milestone specifically relates to the Company’s efforts to satisfy a performance obligation or transfer a distinct good or service within a performance obligation. The Company evaluates each milestone to determine when and how much of the milestone to include in the transaction price. The Company first estimates the amount of the milestone payment that the Company could receive using either the expected value or the most likely amount approach. The Company primarily uses the most likely amount approach as that approach is generally most predictive for milestone payments with a binary outcome. Then, the Company considers whether any portion of that estimated amount is subject to the variable consideration constraint (that is, whether it is probable that a significant reversal of cumulative revenue would not occur upon resolution of the uncertainty). The Company updates the estimate of variable consideration included in the transaction price at each reporting date which includes updating the assessment of the likely amount of consideration and the application of the constraint to reflect current facts and circumstances.

Royalties

For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company will recognize revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any revenue related to sales-based royalties or milestone payments based on the level of sales.

Product Sales, Net

The Company sells COSELA to specialty distributors in the U.S. and, in accordance with ASC 606, recognizes revenue at the point in time when the customer is deemed to have obtained control of the product. The customer is deemed to have obtained control of the product at the time of physical receipt of the product at the customers’ distribution facilities, or Free on Board (“FOB”) destination, the terms of which are designated in the contract.

Product sales are recorded at the net selling price, which includes estimates of variable consideration for which reserves are established for (a) rebates and chargebacks, (b) co-pay assistance programs, (c) distribution fees, (d) product returns, and (e) other discounts. Where appropriate, these estimates take into consideration a range of possible outcomes which are probability-weighted for relevant factors such as current contractual and statutory requirements, and forecasted customer buying and payment patterns. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the applicable contract. The amount of variable consideration may be constrained and is included in the net sales price only to the extent

that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration ultimately received may differ from the Company's estimates. If actual results in the future vary from estimates, the Company adjusts these estimates, which would affect net product revenue and earnings in the period such variances become known.

Liabilities related to co-pay assistance, rebates, and GPO fees are classified as “Accrued Expenses” in the Condensed Balance Sheets. Discounts such as chargebacks, returns, and specialty distributor fees are recorded as a reduction to trade accounts receivable, which is included in “Accounts Receivable” in the Condensed Balance Sheets.

Forms of Variable Consideration

Rebates and Chargebacks: The Company estimates reductions to product sales for Public Health Service Institutions, such as Medicaid, Medicare and Veterans Administration (“VA”) programs, as well as certain other qualifying federal and state government programs, and other group purchasing organizations. The Company estimates these reductions based upon the Company’s contracts with government agencies and other organizations, statutorily defined discounts and estimated payor mix. These organizations purchase directly from the Company’s specialty distributors at a discount and the specialty distributors charge the Company back the difference between the wholesaler price and the discounted price. The Company’s liability for Medicaid rebates consists of estimates for claims that a state will make. The Company’s reserve for this discounted pricing is based on expected sales to qualified healthcare providers and the chargebacks that customers have already claimed.

Co-pay assistance: Eligible patients who have commercial insurance may receive assistance from the Company to reduce the patient’s out of pocket costs. Liabilities for co-pay assistance are calculated by actual program participation from third-party administrators.

Distribution Fees: The Company has written contracts with its customers that include terms for distribution fees and costs for inventory management. The Company estimates and records distribution fees due to its customers based on gross sales.

Product Returns: The Company generally offers a right of return based on the product’s expiration date and certain spoilage and damaged instances. The Company estimates the amount of product sales that may be returned and records the estimate as a reduction of product sales in the period the related product sales are recognized. The Company’s estimates for expected returns are based primarily on an ongoing analysis of sales information and visibility into the inventory remaining in the distribution channel.

Cash and Cash Equivalents

The Company considers all highly liquid investments purchased with an original maturity of three months or less at the date of purchase to be cash equivalents. Cash and cash equivalents at December 31, 2021 and 2020 consist of amounts on deposit in banks, including checking accounts, money market accounts and certificates of deposit. Cash deposits are all in financial institutions in the United States. As part of the lease for the new office space, the Company obtained a standby letter of credit in the amount of $0.5 million related to the security deposit. This letter of credit is secured by money market funds at the financial institution. Therefore, these funds are classified as restricted cash on the balance sheet. The letter of credit will be reduced ratably on each anniversary of the commencement of the lease until the end of the lease term. As of December 31, 2021, restricted cash totaled $0.4 million.

Concentration of Credit Risk

Financial instruments that potentially subject the Company to credit risk consist of cash and cash equivalents. Deposits with financial institutions are insured, up to certain limits, by the Federal Deposit Insurance Corporation (“FDIC”). The Company’s cash deposits often exceed the FDIC insurance limit; however, all deposits are maintained with high credit quality institutions and the Company has not experienced any losses in such accounts. The financial condition of financial institutions is periodically reassessed, and the Company believes the risk of any loss is minimal. The Company believes the risk of any loss on cash due to credit risk is minimal.

Property and Equipment

Property and equipment are stated at cost less accumulated depreciation. Depreciation is generally calculated using the straight-line method over the following estimated useful lives:

Computer equipment			5 years
Laboratory equipment			5 years
Furniture and fixtures			7 years
Leasehold improvements			7 years

Costs associated with maintenance and repairs are charged to expense as incurred. Property and equipment held under leasehold improvements are amortized over the shorter of the lease term or the estimated useful life of the related asset.

Impairment of Long-lived Assets

The Company evaluates its long-lived assets for indicators of possible impairment by comparison of the carrying amounts to future net undiscounted cash flows expected to be generated by such assets when events or changes in circumstances indicate the carrying amount of an asset may not be recoverable. Should an impairment exist, the impairment loss would be measured based on the excess carrying value of the asset over the asset’s fair value based on discounted estimates of future cash flows. For the years ended December 31, 2021, 2020 and 2019, the Company’s management evaluated its long-lived assets and determined no impairment charge was needed.

Cost of Goods Sold

Cost of goods sold includes direct and indirect costs related to the manufacturing and distribution of COSELA, including third-party manufacturing costs, packaging services, freight-in, third-party logistics costs associated with COSELA, and Company personnel costs. Cost of goods sold may also include period costs related to certain inventory manufacturing services and inventory adjustment charges. In connection with the FDA approval of COSELA on February 12, 2021, the Company subsequently began capitalizing inventory manufactured or purchased after this date. As a result, certain manufacturing costs associated with product shipments of COSELA were expensed prior to FDA approval and, therefore, are not included in cost of goods sold during the current period.

Research and Development

Research and development expenses consist of costs incurred to further the Company’s research and development activities and include salaries and related employee benefits, manufacturing of pharmaceutical active ingredients and drug products, costs associated with clinical trials, nonclinical activities, regulatory activities, research-related overhead expenses and fees paid to expert consultants, external service providers and contract research organizations which conduct certain research and development activities on behalf of the Company. Costs incurred in the research and development of products are charged to research and development expense as incurred.

Each reporting period, management estimated and accrued research and development expenses, including external clinical study costs associated with clinical trial activities. The process of estimating and accruing expenses involved reviewing contracts and purchase orders, identifying services that have been provided on the Company’s behalf, and estimating the level of service performed and the associated cost incurred for the service when the Company has not yet been invoiced or otherwise notified of the actual costs.

Costs for clinical trial activities were estimated based on an evaluation of vendors’ progress towards completion of specific tasks, using data such as patient enrollment, clinical site activations or information provided by vendors regarding their actual costs incurred. Payments for these activities are based on the terms of individual contracts and payment timing may differ significantly from the period in which the services were performed. The Company determines accrual estimates through reports from and discussions with applicable personnel and outside service providers as to the progress or state of completion of trials, or the services completed. The estimates of accrued external clinical study costs as of each balance sheet date are based on the facts and circumstances known at the time.

Fair value of Financial Instruments

The Company provides disclosure of financial assets and financial liabilities that are carried at fair value based on the price that would be received upon sale of an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Fair value measurements may be classified based on the amount of subjectivity associated with the inputs to fair valuation of these assets and liabilities using the following three levels:

Level 1		Inputs are unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date.

Level 2		Inputs include quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, inputs other than quoted prices that are observable for the asset or liability and inputs that are derived principally from or corroborated by observable market data by correlation or other means.

Level 3		Unobservable inputs that reflect the Company’s estimates of the assumptions that market participants would use in pricing the asset or liability. The Company develops these inputs based on the best information available, including its own data.

The carrying amounts of cash, cash equivalents, accounts payable and accrued liabilities approximate fair value because of their short-term nature.

At December 31, 2021 and 2020 these financial instruments and respective fair values have been classified as follows (in thousands):

	Quoted prices in active markets for identical assets (Level 1)		Significant other observable inputs (Level 2)		Significant other unobservable inputs (Level 3)		Balance at December 31, 2021
Assets
Money market funds	$	110,443	$	—	$	—	$	110,443
Certificates of Deposit		—		—		—		—
Total assets at fair value:	$	110,443	$	—	$	—	$	110,443

	Quoted prices in active markets for identical assets (Level 1)		Significant other observable inputs (Level 2)		Significant other unobservable inputs (Level 3)		Balance at December 31, 2020
Assets
Money market funds	$	190,180	$	—	$	—	$	190,180
Certificates of Deposit		15,970		—		—		15,970
Total assets at fair value:	$	206,150	$	—	$	—	$	206,150

During the twelve months ended December 31, 2021 and December 31, 2020, there were no changes in valuation methodology.

The Loan Payable (discussed in Note 8), which is classified as a Level 3 liability, has a variable interest rate and the carrying value approximates its fair value. As of December 31, 2021, the carrying value was $75.2 million.

Patent Costs

Costs associated with the submission of patent applications are expensed as incurred given the uncertainty of the future economic benefits of the patents. Patent-related legal expenses included in selling, general and administrative costs were approximately $1,934 thousand, $2,761 thousand, and $2,114 thousand for the years ended December 31, 2021, 2020 and 2019, respectively.

Income Taxes

Income taxes are accounted for using the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to temporary differences between the financial statements carrying amounts of assets and liabilities and their respective tax bases, operating loss carryforwards, and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date.

In accordance with Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) 740, Accounting for Income Taxes, the Company reflects in the financial statements the benefit of positions taken in a previously filed tax return or expected to be taken in a future tax return only when it is considered ‘more-likely-than-not’ that the position taken will be sustained by a taxing authority. As of December 31, 2021 and 2020, the Company had no unrecognized income tax benefits and correspondingly there is no impact on the Company’s effective income tax rate associated with these items. The Company’s policy for recording interest and penalties relating to uncertain income tax positions is to record them as a component of income tax expense in the accompanying statements of operations. As of December 31, 2021 and 2020, the Company had no such accruals.

Stock-Based Compensation

The primary type of stock-based payments utilized by the Company are stock options. The Company accounts for stock-based employee compensation arrangements by measuring the cost of employee services received in exchange for all equity awards granted

based on the fair value of the award on the grant date. The fair value of each employee stock option is estimated on the date of grant using an options pricing model. The Company currently uses the Black-Scholes valuation model to estimate the fair value of its share-based payments. The model requires management to make a number of assumptions including expected volatility, expected life, risk-free interest rate and expected dividends.

The Company also incurs stock-based compensation expense related to restricted stock units (“RSUs”) granted to employees. The fair value of RSUs is determined by the closing market price of the Company’s common stock on the date of grant and then recognized over the requisite service period of the award.

Segment Information

The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. All of the Company’s assets are held in the United States.

Comprehensive Loss

Comprehensive loss includes net loss as well as other changes in stockholders’ equity (deficit) that result from transactions and economic events other than those with stockholders. There was no difference between net loss and comprehensive loss for each of the periods presented in the accompanying financial statements.

Leases

We determine if an arrangement is a lease at inception. Operating lease assets represent our right to use an underlying asset for the lease term and lease liabilities represent our obligation to make lease payments arising from the lease. Operating leases are included in operating lease assets, other current liabilities, and operating lease liabilities on our balance sheet at December 31, 2021. Operating lease assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. As most of our leases do not provide an implicit rate, we use our incremental borrowing rate based on the information available at commencement date to determine the present value of future payments. Our lease terms may include options to extend or terminate the lease when it is reasonably certain that we will exercise that option. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term.

Debt Issuance Costs

Debt issuance costs are amortized to interest expense over the estimated life of the related debt based on the effective interest method. In accordance with ASC 835, Interest, we present debt issuance costs on the condensed balance sheet as a direct deduction from the associated debt.

Coronavirus (COVID-19) Impact on Operations

The Company has implemented business continuity plans to address the COVID-19 pandemic and minimize disruptions to ongoing operations. To date, enrollment of patients in current clinical trials have not been impacted by COVID-19. Although the Company has not had any significant supply chain delays or shortages as a result of the COVID-19 pandemic to date, the Company has experienced delays in the delivery of its investigational product to certain investigative sites due to shortages of ancillary materials and the delay of governmental inspections. To date, the Company is on track to meet all of its previously announced clinical milestones. COVID-19 travel limitations and government-mandated work-from-home or shelter-in-place orders, has reduced the number of in-person meetings in 2021 with prescribers and fewer patient visits with physicians, potentially resulting in fewer new prescriptions.

The Company established a COVID-19 response team which continually monitors the impact of COVID-19 on its operations. The COVID-19 response team manages workplace protocols that govern employees use of our office. To mitigate the impact of COVID-19 on its business, the Company put in place the following safety measures for its employees, patients, healthcare professionals, and suppliers to limit exposure: the Company substantially restricted travel, supplied personal protective equipment to employees, limited access to its headquarters and asked most of its staff to work remotely. In addition, the Company transitioned most of its employees to working remotely and added bandwidth and VPN capacity to its infrastructure. The Company will continue to monitor the impact of COVID-19 on its operations, including how it will impact our employees, clinical trials, development programs, supply chain, and other aspects of our operations, and report to the Board regularly on the progress of its response to the COVID-19 outbreak.

Inventories

12 Months Ended

Dec. 31, 2021

Inventory Disclosure [Abstract]

Inventories

3. Inventories

Inventories consists of the following (in thousands):

	December 31, 2021		December 31, 2020

Raw materials	$	2,105	$	—
Work in process		1,342		—
Finished goods		24		—
Inventories	$	3,471	$	—

The Company uses third party contract manufacturing organizations for the production of its raw materials, active pharmaceutical ingredients, and finished drug product which the Company owns. Costs incurred by the Company for manufacturing of initial commercial product of COSELA in preparation of commercial launch were expensed prior to FDA approval.

Property and Equipment

12 Months Ended

Dec. 31, 2021

Property Plant And Equipment [Abstract]

Property and Equipment

4. Property and Equipment

Property and equipment consists of the following (in thousands):

	December 31, 2021			December 31, 2020

Computer equipment	$	327		$	327
Laboratory equipment		334			334
Furniture and fixtures		866			866
Leasehold improvements		1,782			1,782
Accumulated depreciation		(1,296	)		(827	)
Property and equipment, net	$	2,013		$	2,482

Depreciation expenses relating to property and equipment were $469 thousand, $582 thousand, and $356 thousand for the years ended December 31, 2021, 2020 and 2019, respectively.

Patent License Agreement

12 Months Ended

Dec. 31, 2021

Patent License Agreement [Abstract]

Patent License Agreement

5. Patent License Agreement

On November 23, 2016, the Company entered into a license agreement with the Board of Trustees of the University of Illinois (“the University”), which was amended on March 24, 2017. Pursuant to the license agreement, as amended, the University licensed patent rights to the Company, with rights of sublicense, to make, have made, use, import, sell and offer for sale products covered by certain patent rights owned by the University. The rights licensed to the Company are exclusive, worldwide, non-transferable rights, for all fields of use. Under the terms of the agreement the Company paid a one-time only, non-refundable license issue fee in the amount of $0.5 million which was charged to research and development expense in the fourth quarter of 2016.

The Company is also obligated to pay annual maintenance fees to the University. All annual minimum payments are fully creditable against any royalty payments made by the Company. Under the terms of the agreement, the Company must pay the University royalty percentage on all net sales of products and a share of sublicensing revenues. In addition, the University is eligible to receive milestone payments of up to $2.6 million related to the initiation and execution of clinical trials and the first commercial sale of a product in another country. To date, the Company has made milestone payments totaling $0.6 million, of which $0 was incurred during 2021. The Company will be responsible for any future patent prosecution costs that may arise.

The term of the license agreement will continue until the later of (i) the expiration of the last valid claim within the patent rights covering the product in such country, (ii) the expiration of market exclusivity in such country and (iii) the 10th anniversary of the first commercial sale in such country. The University may terminate the agreement in the event (i) the Company fails to pay any amount or make any report when required to be made and fails to cure such failure within thirty (30) days after receipt of notice from the University, (ii) is in breach of any provision of the agreement and fails to remedy within forty-five (45) days after receipt of notice, (iii) makes a report to the University under the agreement that is determined to be materially false, (iv) declares insolvency or bankruptcy or (v) takes an action that causes patent rights or technical information to be subject to lien or encumbrance and fails to remedy any such breach with in forty-five (45) days of receipt of notice from the University. The Company may terminate the agreement at any time on written notice to the University at least ninety (90) days prior to the termination date specified in the notice. Upon expiration or termination of the agreement, all rights revert to the University.

Accrued Expenses

12 Months Ended

Dec. 31, 2021

Payables And Accruals [Abstract]

Accrued Expenses

6. Accrued Expenses

Accrued expenses are comprised as follows (in thousands):

	December 31, 2021		December 31, 2020

Accrued external research	$	773	$	3,219
Accrued professional fees and other		8,058		3,920
Accrued external clinical study costs		9,579		5,683
Accrued compensation expense		4,770		3,664
Accrued expenses	$	23,180	$	16,486

Leases

12 Months Ended

Dec. 31, 2021

Leases [Abstract]

Leases

7. Leases

We adopted ASC 842 as of January 1, 2019. Prior period amounts have not been adjusted and continue to be reported in accordance with our historic accounting under ASC 840.

Pursuant to a lease agreement dated January 10, 2014 (the “Lease”), on April 1, 2014, the Company leased office and lab space with a free rent period and escalating rent payments; the Lease had an expiration date of July 31, 2017. The Lease was amended on January 27, 2016 to lease new larger office and lab space beginning in August 2016 with a discounted rent period and escalating rent payments and the Lease term was extended to December 31, 2022. The amendment also contained an option for a five-year renewal and a right of first refusal to lease adjacent office space. The Lease was further amended on March 27, 2017 to lease additional office space beginning in August 2017 with a discounted rent period and escalating rent payments. The Lease was amended again in January 2018 to lease additional adjacent office space beginning in August 2018 with a discounted rent period and escalating rent payments. The term of the renewal option contained in the Lease, as amended, was not included in the measurement of the operating lease asset and liability since exercise of the option was uncertain.

On March 20, 2020, the Lease was amended to surrender three of the office spaces previously entered into above, with a termination date of May 31, 2020 and in consideration of a termination fee to be paid. The lease payments and term for the remaining occupied space will remain the same. Due to these changes in lease terms for the three office spaces, in March 2020 the Company modified the operating lease liabilities and operating lease assets of these three office spaces to reflect the new terms.

In November 2018, the Company signed a new lease to secure approximately 60,000 square feet of laboratory and office space at 700 Park Offices Drive in Research Triangle Park, NC (“700 Lease”). The 700 Lease commenced on September 2, 2019 and has an expiration date of September 30, 2027 for the initial term with the Company having the option to renew for an additional 5 years. The term of the renewal option contained in the Lease was not included in the measurement of the operating lease asset and liability since exercise of the option was uncertain. As part of the 700 Lease, the Company obtained a standby letter of credit in the amount of $0.5 million related to the security deposit. This letter of credit is secured by money market funds at the financial institution. Therefore, these funds are classified as restricted cash on the balance sheet. The letter of credit will be reduced ratably on each anniversary of the commencement of the 700 Lease until the end of the lease term.

The tables below reflect the Company’s lease position and weighted-average lease terms and discount rates for our operating leases as of December 31, 2021. Operating lease liabilities are based on the net present value of the remaining lease payments over the remaining lease term. In determining the present value of lease payments, we use our incremental borrowing rate based on the information available at the lease commencement date.


(in thousands)	Classification on the Balance Sheet	December 31, 2021
Assets
Operating lease assets	Operating lease assets	$	7,035
Total lease assets		$	7,035

Liabilities
Current
Operating	Other current liabilities	$	1,115
Non-current
Operating	Operating lease liabilities		6,750
Total lease liabilities		$	7,865

Lease Term and Discount Rate	December 31, 2021
Weighted-average remaining lease term (years)
Operating leases		5.7
Weighted-average discount rate
Operating leases		8.0	%

The table below presents information related to the lease costs for operating leases (in thousands):

		Year Ended December 31,
(in thousands)	Classification	2021		2020		2019

Operating lease costs¹	Research and development	$	799	$	955	$	609
	Selling, general and administrative		870		1,191		368
Total operating lease costs		$	1,669	$	2,146	$	977
¹Includes variable lease costs which are immaterial.

The table below reconciles the undiscounted cash flow for each of the first five years and total of the remaining years to the operating lease liabilities recorded on the balance sheet as of December 31, 2021 (in thousands):

	Operating leases
Years ending December 31,
2022	$	1,703
2023		1,634
2024		1,679
2025		1,725
2026		1,773
Thereafter		1,357
Total future minimum lease payments	$	9,871
Less: present value adjustment		(2,006	)
Total operating lease liabilities	$	7,865

Cash payments included in the measurement of our operating leases were $1,668 thousand for the twelve months ended December 31, 2021.

Loan Payable

12 Months Ended

Dec. 31, 2021

Debt Disclosure [Abstract]

Loan Payable

8. Loan Payable

On May 29, 2020, the Company entered into a loan and security agreement (the “Loan Agreement”) with Hercules Capital, Inc. (“Hercules”), under which Hercules has agreed to lend the Company up to $100.0 million, to be made available in a series of tranches, subject to certain terms and conditions. The first tranche totals $30.0 million, of which the Company received $20.0 million at closing. Upon initiation of the phase 3 trial of COSELA for metastatic colorectal cancer and receiving FDA approval for COSELA for small cell lung cancer (“the Performance Milestone”), the second tranche of $20.0 million became available to the Company for drawdown through December 15, 2021. The third tranche of $30.0 million will be available through December 31, 2022. The fourth tranche of $20.0 million will be available at Hercules’ approval through December 31, 2022. On March 31, 2021, the Company entered into the First Amendment to Loan and Security Agreement (the “First Amendment”) with Hercules whereby the Company drew the remaining $10.0 million of the first tranche and the interest rate and financial covenants were amended. Unless loan advances exceeded $40.0 million, no financial covenants were required.

Amounts borrowed under the Loan Agreement will bear an interest rate equal to the greater of either (i) (a) the prime rate as reported in The Wall Street Journal, plus (b) 6.40%, and (ii) 9.65%. Based on original terms of the Loan Agreement, the Company will make interest only payments through June 1, 2022 and following the interest only period, the Company will repay the principal balance and interest of the advances in equal monthly installments through June 1, 2024. Based on the original terms of the Loan Agreement, upon satisfaction of the Performance Mileston, the interest only period was extended through January 1, 2023 and the maturity date was extended to June 1, 2025. Upon entering into the First Amendment on March 31, 2021, the interest rate was amended to the greater of either (i) (a) the prime rate as reported in The Wall Street Journal, plus (b) 6.20%, and (ii) 9.45%.

The Company may prepay advances under the Loan Agreement, in whole or in part, at any time subject to a prepayment charge equal to (a) 3.0% of the prepayment amount in the first year; (b) 2.0% of the prepayment amount in the second year; and (c) 1.0% of the prepayment amount in the third year.

Upon prepayment or repayment of all or any of the advances under the Loan Agreement, the Company will pay (in addition to the prepayment charge) an end of term charge of 6.95% of the aggregate funded amount. With respect to the first tranche, the end of term charge of $2.1 million will be payable upon any prepayment or repayment. To the extent that the Company is provided additional advances under the Loan Agreement, the 6.95% end of term charge will be applied to such additional amounts. These amounts have been accrued over the term of the loan using effective-interest method.

On November 1, 2021, the Company entered into a Second Amendment to Loan and Security Agreement (the “Second Amendment”) under which Hercules agreed to lend the Company up to $150.0 million, to be made available in a series of tranches, subject to certain terms and conditions. The first tranche was increased to $100.0 million. At close of the Second Amendment, the Company borrowed an additional $45.0 million from Tranche 1 with $25.0 million remaining to be borrowed through September 15, 2022. The second tranche of $20.0 million will become available to the Company upon achievement of $50.0 million trailing six-month net product revenue of COSELA no later than June 30, 2023 and will be available through December 15, 2023. The third tranche of $15.0 million will become available upon achievement of certain development performance milestones and available through December 15, 2023. The fourth tranche of $15.0 million will be available at Hercules’ approval through June 30, 2024.

Amounts borrowed under the Second Amendment will bear an interest rate equal to the greater of either (i) (a) the prime rate as reported in The Wall Street Journal, plus (b) 5.90%, and (ii) 9.15%. The Company will make interest only payments through December 1, 2024 and may be extended through December 1, 2025, in quarterly increments, subject to compliance with covenants of the Second Amendment. Following the interest only period, the Company will repay the principal balance and interest of the advances in equal monthly installments through November 1, 2026.

The Company may prepay advances under the Second Amendment, in whole or in part, at any time subject to a prepayment charge equal to (a) 3.0% of the prepayment amount in the first year from the closing of the Second Amendment; (b) 2.0% of the prepayment amount in the second year from the closing of the Second Amendment; and (c) 1.0% of the prepayment amount in the third year from the closing of the Second Amendment.

Upon prepayment or repayment of all or any of the advances under the Second Amendment, the Company will pay (in addition to the prepayment charge) an end of term charge of 6.75% of the aggregate amount funded. The Company will be required to make a final payment to Hercules in the amount of 6.75% of the amounts funded, less any amount previously paid. In addition, the Company will be required to make a payment to the lender for $2.1 million on the earliest occurrence of (i) June 1, 2025, (ii) the date the Company repays the outstanding principal amount in full, or (iii) the date that the principal amount becomes due and payable in full.

The Second Amendment is secured by substantially all of the Company’s assets, including intellectual property, subject to certain exemptions. The Company out-licensed lerociclib as permitted in the Loan Agreement and the Company may out-license rintodestrant upon approval of the licensing terms by Hercules.

The Second Amendment contains a minimum revenue covenant. Beginning August 15, 2022, with the reporting of the financial results for the second fiscal quarter ended June 30, 2022, and tested monthly, the Company must have achieved net product revenue of COSELA of at least 65% of the amounts projected in the Company’s forecast. Testing of the minimum revenue covenant shall be

waived at any time in which either (a) the Company’s market capitalization exceeds $750.0 million and the Company maintains unrestricted cash equal to at least 50% of the total amounts funded, or (b) the Company maintains unrestricted cash equal to at least 100% of the total amounts funded.

The Company evaluated the Second Amendment under the guidance found in ASC 470-50 Modification and Extinguishment. The Company concluded that the previous debt under the Loan Agreement was extinguished based on the difference in present value of the cash flows of the Loan Agreement and the Second Amendment. Accordingly, the difference between the carrying value of the Loan Agreement as of November 1, 2021, including the unamortized debt issuance costs, and the fair value of the Second Amendment was recorded as a $0.2 million loss on extinguishment of debt for the twelve months ended December 31, 2021. Fees paid to third parties directly related to the funded portion of the Second Amendment have been capitalized as debt issuance costs and will be amortized to interest expense over the life of the Second Amendment using the effective interest method. Fees paid that were directly related to the unfunded portion is account for as a deferred financing charge and amortized to interest expense over the period the unfunded portions are available. The end of term charges associated with the Second Amendment are being accreted through interest expense using the effective interest method over the related term of the debt. During the twelve months ended December 31, 2021, the Company recognized $4.7 million of interest expense related to the debt, inclusive of the loss on extinguishment, which is reflected in other income (expense), net on the statement of operations.

As of December 31, 2021 the future principal payments due under the Loan Agreement, excluding interest, are as follows:

	Amount

2022	$	—
2023		—
2024		2,860
2025		35,993
2026		36,147
Total principal outstanding	$	75,000
End of term charge		1,124
Unamortized debt discount and debt issuance costs		(934	)
Total	$	75,190

- Definition

The entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.

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+ Details

Stockholders' Equity

12 Months Ended

Dec. 31, 2021

Equity [Abstract]

Stockholders' Equity

9. Stockholders’ Equity

Common stock

The Company’s common stock has a par value of $0.0001 per share and consists of 120,000,000 authorized shares as of December 31, 2021 and 2020, respectively. Holders of common stock are entitled to one vote per share and are entitled to receive dividends, as if and when declared by the Company’s Board of Directors.

On June 15, 2018, the Company entered into a sales agreement for “at the market offerings” with Cowen and Company, LLC (“Cowen”), which allowed the Company to issue and sell shares of common stock pursuant to a shelf registration statement for total gross sales proceeds of up to $125.0 million from time to time through Cowen, acting as its agent. Between January 14, 2021 and February 9, 2021, the Company sold 3,513,027 shares of common stock pursuant to this agreement resulting in $86.4 million in net proceeds. As of February 9, 2021, the Company has used the entirety of the remaining availability under the 2018 sales agreement with Cowen.

On July 2, 2021, the Company filed an automatic shelf registration statement on Form S-3 with the Securities and Exchange Commission (the “SEC”), which became effective upon filing, pursuant to which the Company registered for sale an unlimited amount of any combination of its common stock, preferred stock, debt securities, warrants, rights and/or units from time to time and at prices and on terms that the Company may determine, so long as the Company continued to satisfy the requirements of a “well-known seasoned issuer” under SEC rules (the “2021 Form S-3”).

In connection with the 2021 Form S-3, on July 2, 2021, the Company entered into a sales agreement for “at the market offerings” with Cowen, which allowed the Company to issue and sell shares of common stock pursuant to the 2021 Form S-3 for total gross sales proceeds of up to $150.0 million from time to time through Cowen, acting as its agent (the “2021 Sales Agreement”). The Company did not sell any shares of common stock under the 2021 Sales Agreement.

On February 23, 2022, because the Company is no longer a “well-known seasoned issuer” as such term is defined in Rule 405 under the Securities Act of 1933, as amended, the Company filed an automatic post-effective amendment to the 2021 Form S-3 on Form POSASR, which became effective upon filing, to register for sale up to $300.0 million of any combination of its common stock, preferred stock, debt securities, warrants, rights and/or units from time to time and at prices and on terms that the Company may determine and, as required by SEC rules, will file another post-effective amendment to the 2021 Form S-3 on Form POS AM after the filing of this Form 10-K. Once the post-effective amendment to the 2021 Form S-3 on Form POS AM has been declared effective by the SEC, the 2021 Form S-3 will remain in effect for up to three years from the date it originally became effective, which was July 2, 2021. The Company makes no assurances as to the continued effectiveness of the 2021 Form S-3 after the declaration of effectiveness of the post-effective amendment to the 2021 Form S-3 on Form POS AM. The 2021 Form S-3 also includes a prospectus covering up to an aggregate of $100.0 million in common stock that the Company may issue and sell from time to time, through Cowen acting as its sales agent, pursuant to that certain sales agreement that the Company entered into with Cowen on February 23, 2022 (the “2022 Sales Agreement”). In connection with the Company entering into the 2022 Sales Agreement with Cowen, the Company terminated the 2021 Sales Agreement.

Preferred stock

Upon completion of the IPO, all outstanding preferred stock was automatically converted into 18,933,053 shares of common stock. The Company is also authorized to issue 5,000,000 shares of undesignated preferred stock in one or more series. As December 31, 2021, no shares of preferred stock were issued or outstanding.

Shares Reserved for Future Issuance

The Company has reserved authorized shares of common stock for future issuance at December 31, 2021 and December 31, 2020 as follows:

	December 31, 2021		December 31, 2020

Common stock options outstanding		6,701,727		6,644,780
RSUs outstanding		414,991		-
Options and RSUs available for grant under Equity Incentive Plans		1,771,635		932,051
		8,888,353		7,576,831

- Definition

The entire disclosure for shareholders' equity comprised of portions attributable to the parent entity and noncontrolling interest, including other comprehensive income. Includes, but is not limited to, balances of common stock, preferred stock, additional paid-in capital, other capital and retained earnings, accumulated balance for each classification of other comprehensive income and amount of comprehensive income.

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+ Details

Stock-Based Compensation

12 Months Ended

Dec. 31, 2021

Disclosure Of Compensation Related Costs Sharebased Payments [Abstract]

Stock-Based Compensation

10. Stock-Based Compensation

2011 Equity Incentive Plan

In March 2011, the Company adopted the 2011 Equity Incentive Plan (the “Plan”). As amended, 4,400,640 shares of common stock were reserved for issuance under the 2011 Plan. Eligible plan participants included employees, directors, officers, consultants and advisors of the Company. The 2011 plan permitted the granting of incentive stock options, nonqualified stock options and other stock- based awards. In connection with the adoption of the 2017 Plan (as defined below), the 2011 Plan was terminated and no further awards will be made under the 2011 Plan.

2017 Equity Incentive Plan

In May 2017, the Company adopted the 2017 Equity Incentive Plan (the “2017 Plan”). The 2017 Plan provided for the direct award or sale of the Company’s common stock and for the grant of up to 1,932,000 stock options to employees, directors, officers, consultants and advisors of the Company. The 2017 Plan provides for the grant of incentive stock options, non-statutory stock options or restricted stock. Effective January 1, 2021, and in accordance with the “evergreen” provision of the 2017 plan, an additional 1,096,553 shares were made available for issuance.

Under both the 2011 Plan and the 2017 Plan, options to purchase the Company’s common stock may be granted at a price no less than the fair market value of a share of common stock on the date of grant. The fair value shall be the closing sales price for a share as quoted on any established securities exchange for such grant date or the last preceding date for which such quotation exists. Vesting terms of options issued are determined by the Board of Directors or Compensation Committee of the Board. The Company’s stock options vest based on terms in the stock option agreements. Stock options have a maximum term of ten years.

Beginning in January 2021, the Company began granting Restricted Stock Units (“RSUs”) under the 2017 Plan. RSUs are granted at the fair market value of a share of common stock on the date of grant.

As of December 31, 2021, there were a total of 1,307,735 shares of common stock available for future issuance under the 2017 Plan.

2021 Inducement Equity Incentive Plan

In February 2021, the Company adopted the 2021 Inducement Equity Incentive Plan (the “2021 Inducement Plan”). The 2021 Inducement Plan provides for the grant of up to 500,000 non-qualified options, stock grants, and stock-based awards to employees and directors of the Company. The 2021 Inducement Plan does not include an evergreen provision.

As of December 31, 2021, there were a total of 68,900 shares of common stock available for future issuance under the 2021 Inducement Plan.

2021 Sales Force Inducement Equity Incentive Plan

In September 2021, the Company adopted the 2021 Sales Force Inducement Equity Incentive Plan (the “2021 Sales Force Inducement Plan”). The 2021 Sales Force Inducement Plan provides for the grant of up to 500,000 non-qualified options, stock grants, and stock-based awards to sales force individuals and support staff that were not previously employees or directors of the Company. The 2021 Sales Force Inducement Plan does not include an evergreen provision.

As of December 31, 2021, there were a total of 395,000 shares of common stock available for future issuance under the 2021 Sales Force Inducement Plan.

Stock-based Compensation

The Company recognizes compensation costs related to stock options granted to employees based on the estimated fair value of the awards on the date of grant, net of estimated forfeitures. The grant date fair value of the stock-based awards is generally recognized on a straight-line basis over the requisite service period, which is generally the vesting period of the respective awards. Share-based awards granted to non-employee directors as compensation for serving on the Company’s Board of Directors are accounted for in the same manner as employee share-based compensation awards.

The Company calculates the fair value of stock options using the Black-Scholes option pricing model. The Black-Scholes option-pricing model requires the use of subjective assumptions, including the expected volatility of the Company’s common stock, the assumed dividend yield, the expected term of the Company’s stock options and the fair value of the underlying common stock on the date of grant.

The Company also incurs stock-based compensation expense related to RSUs. The fair value of RSUs is determined by the closing market price of the Company’s common stock on the date of grant and then recognized over the requisite service period of the award.

During the years ended December 31, 2021, 2020 and 2019, the Company recorded employee share-based compensation expense of $22,319, $18,770, and $16,351, respectively. The Company recorded non-employee share-based compensation expense of $0, $0, and $98 during the years ended December 31, 2021, 2020 and 2019, respectively. Total share-based compensation expense included in the statements of operations is as follows:

	Year Ended December 31,
	2021		2020		2019
	in thousands
Cost of goods sold	$	252	$	—	$	—
Research and development		4,811		6,902		6,261
Selling, general and administrative		17,256		11,868		10,188
Total stock-based compensation expense	$	22,319	$	18,770	$	16,449

Stock options – Black-Scholes inputs

The fair value of each option grant is estimated on the grant date using the Black-Scholes option-pricing model, using the following weighted average assumptions:

	Year Ended December 31,
	2021		2020		2019

Expected volatility	76.8 - 79.6%		74.8 - 81.0%		74.2 - 82.1%
Weighted-average risk free rate	0.4-1.3%		0.3-1.7%		1.4 - 2.6%
Dividend yield	—%		—%		—%
Expected term (in years)	6.00		6.02		6.02
Weighted-average grant-date fair value per share	$	11.93	$	12.17	$	14.94

The expected term of stock options represents the weighted-average period the stock options are expected to remain outstanding and is based on the option vesting term, contractual terms and industry peers as the Company did not have sufficient historical information to develop reasonable expectations about future exercise patterns and post-vesting employment termination behavior.

The expected stock price volatility assumptions for the Company’s stock options were determined by examining the historical volatilities for industry peers as the Company does not have sufficient history to estimate volatility using only its common stock. In 2019, the Company began incorporating its historical stock price in conjunction with selected similar publicly traded companies. The Company plans to continue to use the guideline peer group volatility information until the historical volatility of its common stock is sufficient to measure expected volatility for future option grants.

The risk-free interest rate assumption at the date of grant is based on the U.S. Treasury instruments whose term was consistent with the expected term of the Company’s stock options.

The expected dividend assumption is based on the Company’s history and expectation of dividend payouts.

Stock Option Activity

The following table is a summary of stock option activity during 2021 is as follows:

						Weighted average
				Weighted		Remaining
				average		contractual		Aggregate
	Options			exercise		for		intrinsic
	outstanding			price		life (Years)		value
								(in thousands)
Balance as of December 31, 2020		6,644,780		$	16.91		7.3	$	35,464
Granted		2,168,053			17.77
Cancelled		(1,176,075	)		21.40
Exercised		(935,031	)		6.25
Balance as of December 31, 2021		6,701,727		$	17.88		7.2	$	10,427
Exercisable at December 31, 2021		3,660,578			16.72		5.9		10,422
Vested at December 31, 2021 and expected to vest		6,701,727			17.88		7.2		10,427

As of December 31, 2021, unrecognized compensation expense related to unvested stock options totaled $33.5 million, which is expected to be recognized over a weighted-average period of approximately 2.4 years.

Prior to our initial public offering, the fair value of our common shares underlying our stock options was estimated on each grant date by our board of directors. In order to determine the fair value of our common shares underlying granted stock options, our board of directors considered, among other things, timely valuations of our common shares prepared by an unrelated third-party valuation firm in accordance with the guidance provided by the American Institute of Certified Public Accountants Practice Guide, Valuation of Privately-Held-Company Equity Securities Issued as Compensation.

Since the IPO, the board of directors has determined the fair value of each common share underlying share-based awards based on the closing price of the common shares as reported by Nasdaq on the date of grant.

Restricted Stock Units

The Company’s restricted stock units (“RSUs”) are considered nonvested share awards and require no payment from the employee. For each RSU, employees receive one common share at the end of the vesting period. Compensation cost is recorded based on the market price of the Company’s common stock on the grant date and is recognized on a straight-line basis over the requisite service period.

The following table is a summary of the RSU activity for the twelve months ended December 31, 2021:

				Weighted - Average
	Number of			Fair Value
	RSUs			per Share

Balance as of December 31, 2020		—		$	—
Granted		507,906			18.20
Cancelled		(92,915	)		18.07
Vested		—			—
Balance as of December 31, 2021		414,991		$	18.24

As of December 31, 2021, there was $5.2 million of total unrecognized compensation cost related to Company RSUs that are expected to vest. These costs are expected to be recognized over a weighted-average period of approximately 2.4 years.

License Revenue

12 Months Ended

Dec. 31, 2021

Revenue Recognition [Abstract]

License Revenue

11. License Revenue

ARC License Agreement

On May 22, 2020, the Company entered into an exclusive license agreement with ARC Therapeutics, LLC (“ARC”), a company primarily owned by a related party, whereby the Company granted to ARC an exclusive, worldwide, royalty-bearing license, with the right to sublicense, solely to make, have made, use, sell, offer for sale, import, export, and commercialize products related to its cyclin dependent kinase 2 (“CDK2”) inhibitor compounds. At close, the Company received consideration in the form of an upfront payment of $1.0 million and an equity interest in ARC equal to 10% of its issued and outstanding units valued at $1.1 million. In addition, the Company may receive a future development milestone payment totaling $2.0 million and royalty payments in the mid-single digits based on net sales of the licensed compound after commercialization. The Company has right of first negotiation to re-acquire these assets.

The Company assessed the license agreement in accordance with ASC 606 and identified one performance obligation in the contract, which is the transfer of the license, as ARC can benefit from the license using its own resources. The Company recognized $2.1 million in license revenue consisting of the upfront payment and the 10% equity interest in ARC upon the effective date as the Company determined the license was a right to use the intellectual property and the Company had provided all necessary information to ARC to benefit from the license.

The Company considers the future potential development milestones and sales-based royalties to be variable consideration. The development milestone is excluded from the transaction price because it determined the payment to be fully constrained under ASC 606 due to the inherent uncertainty in the achievement of such milestone due to factors outside of the Company’s control. As sales-based royalties are all related to the license of the intellectual property, the Company will recognize revenue in the period when subsequent sales are made pursuant to the sales-based royalty exception. The Company will re-evaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur.

There was no revenue recognized during the twelve months ended December 31, 2021.

Genor License Agreement

On June 15, 2020, the Company entered into an exclusive license agreement with Genor Biopharma Co. Inc. (“Genor”) for the development and commercialization of lerociclib in the Asia-Pacific region, excluding Japan (the “Genor Territory”). Under the license agreement, the Company granted to Genor an exclusive, royalty-bearing, non-transferable license, with the right to grant sublicenses, to develop, obtain, hold and maintain regulatory approvals for, and commercialize lerociclib, in the Genor Territory.

Under the license agreement, Genor agreed to pay the Company a non-refundable, upfront cash payment of $6.0 million with the potential to pay an additional $40.0 million upon reaching certain development and commercial milestones. In addition, Genor will pay the Company tiered royalties ranging from high single to low double-digits based on annual net sales of lerociclib in the Genor Territory. In September 2020, the Company transferred to Genor the related technology and know-how that is necessary to develop, seek regulatory approval for, and commercialize lerociclib in the Genor Territory, which resulted in the recognition of $6.0 million in revenue in accordance with ASC 606.

During the twelve months ended December 31, 2021, the Company recognized $3.0 million of revenue related to development milestones which occurred during the year.

EQRx License Agreement

On July 22, 2020, the Company entered into an exclusive license agreement with EQRx, Inc. (“EQRx”) for the development and commercialization of lerociclib in the U.S., Europe, Japan and all other global markets, excluding the Asia-Pacific region (except Japan) (the “EQRx Territory”). Under the license agreement, the Company granted to EQRx an exclusive, royalty-bearing, non-transferable license, with the right to grant sublicenses, to develop, obtain, hold and maintain regulatory approvals for, and commercialize lerociclib in the EQRx Territory.

Under the license agreement, EQRx agreed to pay the Company a non-refundable, upfront cash payment of $20.0 million with the potential to pay an additional $290.0 million upon reaching certain development and commercial milestones. In addition, EQRx will pay the Company tiered royalties ranging from mid-single digits to mid-teens based on annual net sales of lerociclib in the EQRx Territory. In September 2020, the Company transferred to EQRx the related technology and know-how that is necessary to develop, seek regulatory approval for, and commercialize lerociclib in the EQRx Territory which resulted in the recognition of $20.0 million in revenue in accordance with ASC 606. EQRx will be responsible for the development of the product in the EQRx Territory. The Company will continue until completion, as the clinical trial sponsor, its two primary clinical trials at EQRx’s sole cost and expense. EQRx will reimburse the Company for all of its out-of-pocket costs incurred after the effective date of the license agreement in connection with these clinical trials. The Company will invoice EQRx within 30 days following the end of the quarter, and EQRx will pay within 30 days after its receipt of such invoice.

For the twelve months ended December 31, 2021the Company recognized revenue of $4.8 million related to the delivery of clinical drug supply and manufacturing services and $2.5 million for the reimbursement of costs associated with the two primary clinical trials for lerociclib. The amounts for clinical drug supply and manufacturing services have been invoiced and paid. The amounts for clinical trial reimbursements that occurred during the quarter are recognized as accounts receivable on the balance sheet as of December 31, 2021. No development and commercial milestones, as defined by the agreement, have been achieved through December 31, 2021.

Simcere License Agreement

On August 3, 2020, the Company entered into an exclusive license agreement with Nanjing Simcere Dongyuan Pharmaceutical Co., Ltd (“Simcere”) for the development and commercialization of trilaciclib in all indications in Greater China (mainland China, Hong Kong, Macau, and Taiwan) (the “Simcere Territory”). Under the license agreement, the Company granted to Simcere an exclusive, royalty-bearing, non-transferable license, with the right to grant sublicenses, to develop, obtain, hold and maintain regulatory approvals for, and commercialize trilaciclib in the Simcere Territory.

Under the license agreement, Simcere agreed to pay the Company a non-refundable, upfront cash payment of $14.0 million with the potential to pay an additional $156.0 million upon reaching certain development and commercial milestones. In addition, Simcere will pay the Company tiered low double-digit royalties on annual net sales of trilaciclib in the Simcere Territory. In accordance with ASC 606, the Company recognized the non-fundable, upfront cash payment of $14.0 million (less applicable withholding taxes of $1.4 million) 2020 as the Company had transferred the license and related technology and know-how to Simcere.

During the twelve months ended December 31, 2021 the Company recognized $8.0 million (less applicable withholding taxes of $0.8 million) related to development milestones which were met during the period and $1.0 million for the reimbursement of clinical trial costs.

- Definition

The entire disclosure of revenue from contract with customer to transfer good or service and to transfer nonfinancial asset. Includes, but is not limited to, disaggregation of revenue, credit loss recognized from contract with customer, judgment and change in judgment related to contract with customer, and asset recognized from cost incurred to obtain or fulfill contract with customer. Excludes insurance and lease contracts.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-URI http://asc.fasb.org/topic&trid=49130388

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-Name Accounting Standards Codification
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

Net Loss Per Common Share

12 Months Ended

Dec. 31, 2021

Earnings Per Share [Abstract]

Net Loss Per Common Share

12. Net Loss per Common Share

Basic net loss per common share is computed using the weighted average number of common shares outstanding during the period including nominal issuances of common stock warrants. Diluted net loss per common share is computed using the sum of the weighted average number of common shares outstanding during the period and, if dilutive, the weighted average number of potential shares of common stock, including the assumed exercise of stock options, stock warrants and unvested restricted common stock. For the years ended December 31, 2021, 2020 and 2019, the following potentially dilutive securities have been excluded from the computations of diluted weighted-average shares outstanding because the effect would be anti-dilutive:

	Year Ended December 31,
	2021		2020		2019

Stock options issued and outstanding		7,056,745		6,576,688		5,443,730
Unvested RSU		451,138		—		—
Total potential diluted shares		7,507,883		6,576,688		5,443,730

Amounts in the table above reflect the common stock equivalents of the noted instruments.

Income Taxes

12 Months Ended

Dec. 31, 2021

Income Tax Disclosure [Abstract]

Income Taxes

13. Income Taxes

In accordance with FASB ASC 740, Accounting for Income Taxes, the Company reflects in the financial statements the benefit of positions taken in a previously filed tax return or expected to be taken in a future tax return only when it is considered ‘more-likely-than-not’ that the position taken will be sustained by a taxing authority. As of December 31, 2021 and 2020, the Company had no unrecognized income tax benefits and correspondingly there is no impact on the Company’s effective income tax rate associated with these items. The Company’s policy for recording interest and penalties relating to uncertain income tax positions is to record them as a component of income tax expense in the accompanying statements of operations. As of December 31, 2021 and 2020, the Company had no such accruals.

The components of income tax expense (benefit) attributable to continuing operations are as follows:

	Year ended December 31,
	2021		2020		2019
Current Expense:
Federal	$	—	$	—	$	—
State		—		—		—
Foreign		925		1,410		—
		925		1,410		—
Deferred Expense:
Federal		—		—		—
State		—		—		—
Foreign		—		—		—
	$	925	$	1,410	$	—

The differences between the company’s income tax expense attributable to continuing operations and the expense computed at the 21% U.S. statutory income tax rate were as follows (in thousands):

	Year ended December 31,
	2021			2020			2019
Federal income tax benefit at statutory rate:	$	(30,960	)	$	(20,547	)	$	(25,714	)
Increase (reduction) in income tax resulting from:
State Income Taxes		(1,923	)		(1,779	)		(2,369	)
Increase in Valuation Allowance		27,618			23,782			29,499
Write off Sec. 382 Limited Carryforwards		—			—			1,858
Stock Compensation		108			1,341			461
Research and Development Credit		(3,030	)		(3,091	)		(3,529	)
NC Tax Rate Change		8,359			—			—
Foreign Withholding Tax		925			1,410			—
Other		(172	)		294			(206	)
	$	925		$	1,410		$	—

On November 18, 2021, North Carolina enacted the 2021 Appropriations Act, which included a gradual corporate income tax rate decrease from the current 2.5% to 0% by 2030. The Company is in a cumulative loss position and does not have significant deferred tax liabilities that can be utilized as a source of taxable income in the future. Therefore, the Company has reduced its North Carolina deferred tax assets, including the NOLs, to zero, as no benefit is expected to be realized from these deferred tax assets prior to 2030 when there would be no income tax in North Carolina. The reduction in the value of the deferred tax assets resulted in $8.4 million of tax expense, which was offset fully by the reduction in the corresponding valuation allowance. If the Company becomes profitable prior to 2030, the Company will recognize an income tax benefit related to the portion of its North Carolina deferred tax assets utilized.

The tax effects of temporary differences and operating loss carryforwards that gave rise to significant portions of the deferred tax assets and deferred tax liabilities were as follows at December 31, 2021 and 2020 (in thousands):

	Year ended December 31,
	2021			2020
Deferred tax assets
Accrued expenses	$	2,633		$	2,863
Operating lease liabilities		1,730			2,034
Stock compensation		9,037			7,147
R&D credits		16,995			13,965
Net operating loss carryforwards		108,489			85,842
Other		191			20
Deferred tax assets		139,075			111,871
Deferred tax liabilities
Operating lease assets		(1,548	)		(1,844	)
Other		(127	)		(245	)
Deferred tax liabilities		(1,675	)		(2,089	)
Valuation allowance		(137,400	)		(109,782	)
Net deferred tax assets	$	—		$	—

At December 31, 2021 and December 31, 2020, the Company evaluated all significant available positive and negative evidence, including the existence of losses in recent years and management’s forecast of future taxable income, and, as a result, determined it was more likely than not that federal and state deferred tax assets, including benefits related to net operating loss carryforwards, would not be realized. The valuation allowance increased $27.6 million from $109.8 million at December 31, 2020 to $137.4 million at December 31, 2021. The increase in valuation allowance was due primarily to the increase in net operating loss carryforwards and income tax credits.

The table below summarizes changes in the deferred tax valuation allowance (in thousands):

	2021			2020			2019
Balance at beginning of year	$	109,782		$	86,000		$	56,501
Charges to costs and expenses		35,961			25,170			31,357
Write-offs¹		(8,343	)		(1,388	)		(1,858	)
Balance at end of year	$	137,400		$	109,782		$	86,000
¹Includes impact of NC enacted tax rate change

At December 31, 2021, the Company has federal net operating loss carryforwards (“NOLs”) of approximately $510.0 million, which are available to offset future taxable income. Of the $510.0 million available, $95.4 million will begin to expire in 2029. The remaining $414.6 million has an indefinite carryforward period. Under the Tax Cuts and Jobs Act (“Tax Act”), federal NOLs arising after December 31, 2017 may be carried forward indefinitely. However, for NOLs arising after December 31, 2017, NOL carryforwards will be limited to 80% of taxable income. The Company’s NOLs generated in 2017 and in prior years will not be subject to the 80% limitation under the Tax Act. In addition, the Company has state net operating loss carryforwards totaling approximately $332.7 million, which are available to offset future state taxable income. The state net operating loss carryforwards are inclusive of North Carolina net operating losses, which are recorded at zero benefit, as discussed in this footnote. State net operating losses begin to expire in 2024. Because the Company has incurred cumulative net operating losses since inception, all tax years remain open to examination by U.S. federal and state income tax authorities. As of December 31, 2021, the Company also had federal

research and development (R&D) credit carryforwards of approximately $17.0 million available to offset future income tax which begin to expire in 2035.

In accordance with FASB ASC 740, Accounting for Income Taxes, the Company reflects in the financial statements the benefit of positions taken in a previously filed tax return or expected to be taken in a future tax return only when it is considered ‘more-likely-than-not’ that the position taken will be sustained by a taxing authority. As of December 31, 2021 and 2020, the Company had no unrecognized income tax benefits and correspondingly there is no impact on the Company’s effective income tax rate associated with these items. The Company’s policy for recording interest and penalties relating to uncertain income tax positions is to record them as a component of income tax expense in the accompanying statements of income. As of December 31, 2021 and 2020, the Company had no such accruals.

Section 382 Limitation

The Company’s ability to utilize its net operating loss and research and development credit carryforwards may be substantially limited due to ownership changes that may have occurred or that could occur in the future, as required by Section 382 of the Internal Revenue Code of 1986, as amended (the Code), as well as similar state provisions. These ownership changes may limit the amount of NOL and R&D credit carryforwards that can be utilized annually to offset future taxable income and tax, respectively. In general, an “ownership change,” as defined by Section 382 of the Code, results from a transaction or series of transactions over a three-year period resulting in an ownership change of more than 50 percent of the outstanding stock of a company by certain stockholders or public groups.

In April 2019, the Company completed an evaluation study as to whether an “ownership change” had occurred and determined that the limitation would be approximately $8.0 million on federal net operating loss carryforwards, $1.2 million on state net operating loss carryforwards, and $0.1 million on R&D tax credit carryforwards. The carryforward amounts reported above have already been reduced for these limitations. The Company continues to maintain a valuation allowance on the remaining NOLs as it believes that it is more likely than not that all of the deferred tax asset associated with the NOLs will not be realized regardless of whether an “ownership change” has occurred.

- Definition

The entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section 50
-Paragraph 21
-URI http://asc.fasb.org/extlink&oid=121826272&loc=d3e32857-109319

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+ Details

Related Party Transactions

12 Months Ended

Dec. 31, 2021

Related Party Transactions

14. Related Party Transactions

The Company maintained a consulting agreement with a Seth A. Rudnick, M.D., a member of the Board of Directors, for scientific advisory services outside of his role on the Board of Directors that expired on June 30, 2021. Under this agreement with the member of the Board of Directors, the Company paid $3,000, $6,000, and $6,000 for the years ended December 31, 2021, 2020, and 2019, respectively. Effective July 1, 2021, the Company renewed its agreement with Dr. Rudnick for scientific, clinical and regulatory advisory services outside of his role on the Board of Directors through June 30, 2022. Pursuant to the terms of the agreement, Dr. Rudnick will receive $50,000 annually, paid in equal semi-annual installments, for his services. The first payment of $25,000 was accrued for as of December 31, 2021. On October 13, 2021, Dr. Rudnick notified the Company of his decision to resign from the Board of Directors of the Company effectively immediately as of October 13, 2021.

The Company entered into a senior advisor agreement on September 29, 2020 with Mark A. Velleca, M.D., Ph.D., a member of the Board of Directors, with an effective date of January 1, 2021. Pursuant to the terms of the agreement, Dr. Velleca will receive $200,000 annually, paid in equal quarterly installments, for his services. The senior advisory agreement will expire on December 31, 2023.

Quarterly Results of Operations (Unaudited)

12 Months Ended

Dec. 31, 2021

Quarterly Financial Information Disclosure [Abstract]

Quarterly Results of Operations (Unaudited)

15. Quarterly Results of Operations (Unaudited)

The following table contains quarterly financial information for 2021 and 2020. The Company believes that the following information reflects all normal recurring adjustments necessary for a fair statement of the information for the periods presented. The operating results for any quarter are not necessarily indicative of results for any future period.

	Three Months Ended
	(unaudited)
	(in thousands, except share and per share amounts)
	March 31,			June 30,			September 30,			December 31,
	2021			2021			2021			2021
Total revenues	$	14,218		$	6,604		$	4,858		$	5,796
Total operating expenses		39,753			44,796			46,002			43,382
Loss from operations		(25,535	)		(38,192	)		(41,144	)		(37,586	)
Total other income (expense), net		(769	)		(1,010	)		(1,003	)		(2,188	)
Loss before income taxes		(26,304	)		(39,202	)		(42,147	)		(39,774	)
Income tax expense		138			220			321			246
Net loss	$	(26,442	)	$	(39,422	)	$	(42,468	)	$	(40,020	)
Net loss per share, basic and diluted	$	(0.65	)	$	(0.94	)	$	(1.00	)	$	(0.94	)
Weighted average common shares outstanding, basic and diluted		40,700,827			42,119,850			42,383,573			42,544,321


	March 31,			June 30,			September 30,			December 31,
	2020			2020			2020			2020
Total revenues	$	—		$	2,140		$	26,599		$	16,546
Total operating expenses		31,821			32,962			36,344			40,634
Loss from operations		(31,821	)		(30,822	)		(9,745	)		(24,088	)
Total other income (expense), net		798			(388	)		(998	)		(780	)
Loss before income taxes		(31,023	)		(31,210	)		(10,743	)		(24,868	)
Income tax expense		—			—			931			479
Net loss	$	(31,023	)	$	(31,210	)	$	(11,674	)	$	(25,347	)
Net loss per share, basic and diluted	$	(0.82	)	$	(0.83	)	$	(0.31	)	$	(0.67	)
Weighted average common shares outstanding, basic and diluted		37,659,722			37,786,208			38,009,204			38,053,609

Basis of Presentation and Summary of Significant Accounting Policies (Policies)

12 Months Ended

Dec. 31, 2021

Accounting Policies [Abstract]

Basis of Presentation

The Company has prepared the accompanying financial statements in conformity with generally accepted accounting principles in the United States of America (“U.S. GAAP”).

Use of Estimates

Accounts Receivable

Inventories

cost of sales in the period in which they are incurred. No inventory valuation adjustments have been recorded for any periods presented.

Revenue Recognition

Licenses of Intellectual Property

Milestone Payments

Royalties

Product Sales, Net

Forms of Variable Consideration

Cash and Cash Equivalents

Concentration of Credit Risk

Property and Equipment

Property and equipment are stated at cost less accumulated depreciation. Depreciation is generally calculated using the straight-line method over the following estimated useful lives:

Computer equipment			5 years
Laboratory equipment			5 years
Furniture and fixtures			7 years
Leasehold improvements			7 years

Impairment of Long-Lived Assets

Impairment of Long-lived Assets

Cost of Goods Sold

Research and Development

Fair Value of Financial Instruments

Fair value of Financial Instruments

Level 1		Inputs are unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date.

Level 2		Inputs include quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, inputs other than quoted prices that are observable for the asset or liability and inputs that are derived principally from or corroborated by observable market data by correlation or other means.

Level 3		Unobservable inputs that reflect the Company’s estimates of the assumptions that market participants would use in pricing the asset or liability. The Company develops these inputs based on the best information available, including its own data.

The carrying amounts of cash, cash equivalents, accounts payable and accrued liabilities approximate fair value because of their short-term nature.

At December 31, 2021 and 2020 these financial instruments and respective fair values have been classified as follows (in thousands):

	Quoted prices in active markets for identical assets (Level 1)		Significant other observable inputs (Level 2)		Significant other unobservable inputs (Level 3)		Balance at December 31, 2021
Assets
Money market funds	$	110,443	$	—	$	—	$	110,443
Certificates of Deposit		—		—		—		—
Total assets at fair value:	$	110,443	$	—	$	—	$	110,443

	Quoted prices in active markets for identical assets (Level 1)		Significant other observable inputs (Level 2)		Significant other unobservable inputs (Level 3)		Balance at December 31, 2020
Assets
Money market funds	$	190,180	$	—	$	—	$	190,180
Certificates of Deposit		15,970		—		—		15,970
Total assets at fair value:	$	206,150	$	—	$	—	$	206,150

During the twelve months ended December 31, 2021 and December 31, 2020, there were no changes in valuation methodology.

Patent Costs

Income Taxes

Stock-Based Compensation

Segment Information

The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. All of the Company’s assets are held in the United States.

Comprehensive Loss

Leases

Debt Issuance Costs

Coronavirus (COVID-19) Impact on Operations

Basis of Presentation and Summary of Significant Accounting Policies (Tables)

12 Months Ended

Dec. 31, 2021

Accounting Policies [Abstract]

Schedule of Property and Equipment Estimated Useful Lives

Depreciation is generally calculated using the straight-line method over the following estimated useful lives:

Computer equipment			5 years
Laboratory equipment			5 years
Furniture and fixtures			7 years
Leasehold improvements			7 years

Summary of Financials Instruments and Respective Fair Values

At December 31, 2021 and 2020 these financial instruments and respective fair values have been classified as follows (in thousands):

	Quoted prices in active markets for identical assets (Level 1)		Significant other observable inputs (Level 2)		Significant other unobservable inputs (Level 3)		Balance at December 31, 2021
Assets
Money market funds	$	110,443	$	—	$	—	$	110,443
Certificates of Deposit		—		—		—		—
Total assets at fair value:	$	110,443	$	—	$	—	$	110,443

	Quoted prices in active markets for identical assets (Level 1)		Significant other observable inputs (Level 2)		Significant other unobservable inputs (Level 3)		Balance at December 31, 2020
Assets
Money market funds	$	190,180	$	—	$	—	$	190,180
Certificates of Deposit		15,970		—		—		15,970
Total assets at fair value:	$	206,150	$	—	$	—	$	206,150

Inventories (Tables)

12 Months Ended

Dec. 31, 2021

Inventory Disclosure [Abstract]

Schedule of Inventories

Inventories consists of the following (in thousands):

	December 31, 2021		December 31, 2020

Raw materials	$	2,105	$	—
Work in process		1,342		—
Finished goods		24		—
Inventories	$	3,471	$	—

Property and Equipment (Tables)

12 Months Ended

Dec. 31, 2021

Property Plant And Equipment [Abstract]

Schedule of Property and Equipment

Property and equipment consists of the following (in thousands):

	December 31, 2021			December 31, 2020

Computer equipment	$	327		$	327
Laboratory equipment		334			334
Furniture and fixtures		866			866
Leasehold improvements		1,782			1,782
Accumulated depreciation		(1,296	)		(827	)
Property and equipment, net	$	2,013		$	2,482

Accrued Expenses (Tables)

12 Months Ended

Dec. 31, 2021

Payables And Accruals [Abstract]

Schedule of Accrued Expenses

Accrued expenses are comprised as follows (in thousands):

	December 31, 2021		December 31, 2020

Accrued external research	$	773	$	3,219
Accrued professional fees and other		8,058		3,920
Accrued external clinical study costs		9,579		5,683
Accrued compensation expense		4,770		3,664
Accrued expenses	$	23,180	$	16,486

Leases (Tables)

12 Months Ended

Dec. 31, 2021

Leases [Abstract]

Summary of Lease Position and Weighted-Average Lease Term and Discount Rate of Operating Leases


(in thousands)	Classification on the Balance Sheet	December 31, 2021
Assets
Operating lease assets	Operating lease assets	$	7,035
Total lease assets		$	7,035

Liabilities
Current
Operating	Other current liabilities	$	1,115
Non-current
Operating	Operating lease liabilities		6,750
Total lease liabilities		$	7,865

Lease Term and Discount Rate	December 31, 2021
Weighted-average remaining lease term (years)
Operating leases		5.7
Weighted-average discount rate
Operating leases		8.0	%

Summary of Information Related to Lease Costs for Operating Leases

The table below presents information related to the lease costs for operating leases (in thousands):

		Year Ended December 31,
(in thousands)	Classification	2021		2020		2019

Operating lease costs¹	Research and development	$	799	$	955	$	609
	Selling, general and administrative		870		1,191		368
Total operating lease costs		$	1,669	$	2,146	$	977
¹Includes variable lease costs which are immaterial.

Reconciliation of Undiscounted Cash Flow to Operating Lease Liabilities

	Operating leases
Years ending December 31,
2022	$	1,703
2023		1,634
2024		1,679
2025		1,725
2026		1,773
Thereafter		1,357
Total future minimum lease payments	$	9,871
Less: present value adjustment		(2,006	)
Total operating lease liabilities	$	7,865

Loan Payable (Tables)

12 Months Ended

Dec. 31, 2021

Debt Disclosure [Abstract]

Schedule of Outstanding Debt Obligations

As of December 31, 2021 the future principal payments due under the Loan Agreement, excluding interest, are as follows:

	Amount

2022	$	—
2023		—
2024		2,860
2025		35,993
2026		36,147
Total principal outstanding	$	75,000
End of term charge		1,124
Unamortized debt discount and debt issuance costs		(934	)
Total	$	75,190

Stockholders' Equity (Tables)

12 Months Ended

Dec. 31, 2021

Equity [Abstract]

Summary of Common Stock Shares Reserved for Future Issuance

The Company has reserved authorized shares of common stock for future issuance at December 31, 2021 and December 31, 2020 as follows:

	December 31, 2021		December 31, 2020

Common stock options outstanding		6,701,727		6,644,780
RSUs outstanding		414,991		-
Options and RSUs available for grant under Equity Incentive Plans		1,771,635		932,051
		8,888,353		7,576,831

- Definition

Tabular disclosure of an entity's stock, including par or stated value per share, number and dollar amount of share subscriptions, shares authorized, shares issued, shares outstanding, number and dollar amount of shares held in an employee trust, dividend per share, total dividends, share conversion features, par value plus additional paid in capital, the value of treasury stock and other information necessary to a fair presentation, and EPS information. Stock by class includes common, convertible, and preferred stocks which are not redeemable or redeemable solely at the option of the issuer. Includes preferred stock with redemption features that are solely within the control of the issuer and mandatorily redeemable stock if redemption is required to occur only upon liquidation or termination of the reporting entity. If more than one issue is outstanding, state the title of each issue and the corresponding dollar amount; dollar amount of any shares subscribed but unissued and the deduction of subscriptions receivable there from; number of shares authorized, issued, and outstanding.

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+ Details

Stock-Based Compensation (Tables)

12 Months Ended

Dec. 31, 2021

Summary of Stock Option Activity

The following table is a summary of stock option activity during 2021 is as follows:

						Weighted average
				Weighted		Remaining
				average		contractual		Aggregate
	Options			exercise		for		intrinsic
	outstanding			price		life (Years)		value
								(in thousands)
Balance as of December 31, 2020		6,644,780		$	16.91		7.3	$	35,464
Granted		2,168,053			17.77
Cancelled		(1,176,075	)		21.40
Exercised		(935,031	)		6.25
Balance as of December 31, 2021		6,701,727		$	17.88		7.2	$	10,427
Exercisable at December 31, 2021		3,660,578			16.72		5.9		10,422
Vested at December 31, 2021 and expected to vest		6,701,727			17.88		7.2		10,427

Summary of Restricted Stock Units Activity

The following table is a summary of the RSU activity for the twelve months ended December 31, 2021:

				Weighted - Average
	Number of			Fair Value
	RSUs			per Share

Balance as of December 31, 2020		—		$	—
Granted		507,906			18.20
Cancelled		(92,915	)		18.07
Vested		—			—
Balance as of December 31, 2021		414,991		$	18.24

Employee and Non-employee Stock Options

Summary of Share-Based Compensation Expense Included in Statements of Operations

Total share-based compensation expense included in the statements of operations is as follows:

	Year Ended December 31,
	2021		2020		2019
	in thousands
Cost of goods sold	$	252	$	—	$	—
Research and development		4,811		6,902		6,261
Selling, general and administrative		17,256		11,868		10,188
Total stock-based compensation expense	$	22,319	$	18,770	$	16,449

Summary of Fair Value of Stock Options Granted Using Black-Scholes Options Pricing Model

The fair value of each option grant is estimated on the grant date using the Black-Scholes option-pricing model, using the following weighted average assumptions:

	Year Ended December 31,
	2021		2020		2019

Expected volatility	76.8 - 79.6%		74.8 - 81.0%		74.2 - 82.1%
Weighted-average risk free rate	0.4-1.3%		0.3-1.7%		1.4 - 2.6%
Dividend yield	—%		—%		—%
Expected term (in years)	6.00		6.02		6.02
Weighted-average grant-date fair value per share	$	11.93	$	12.17	$	14.94

Net Loss Per Common Share (Tables)

12 Months Ended

Dec. 31, 2021

Earnings Per Share [Abstract]

Schedule of Potentially Dilutive Securities Excluded from Computations of Diluted Weighted-average Shares Outstanding

For the years ended December 31, 2021, 2020 and 2019, the following potentially dilutive securities have been excluded from the computations of diluted weighted-average shares outstanding because the effect would be anti-dilutive:

	Year Ended December 31,
	2021		2020		2019

Stock options issued and outstanding		7,056,745		6,576,688		5,443,730
Unvested RSU		451,138		—		—
Total potential diluted shares		7,507,883		6,576,688		5,443,730

Income Taxes (Tables)

12 Months Ended

Dec. 31, 2021

Income Tax Disclosure [Abstract]

Components of Income Tax Expense (Benefit) Attributable to Continuing Operations

The components of income tax expense (benefit) attributable to continuing operations are as follows:

	Year ended December 31,
	2021		2020		2019
Current Expense:
Federal	$	—	$	—	$	—
State		—		—		—
Foreign		925		1,410		—
		925		1,410		—
Deferred Expense:
Federal		—		—		—
State		—		—		—
Foreign		—		—		—
	$	925	$	1,410	$	—

Summary of Differences Between the Income Tax Expense Attributable to Continuing Operations and the Expense Computed at U.S. Statutory Income Tax Rate

The differences between the company’s income tax expense attributable to continuing operations and the expense computed at the 21% U.S. statutory income tax rate were as follows (in thousands):

	Year ended December 31,
	2021			2020			2019
Federal income tax benefit at statutory rate:	$	(30,960	)	$	(20,547	)	$	(25,714	)
Increase (reduction) in income tax resulting from:
State Income Taxes		(1,923	)		(1,779	)		(2,369	)
Increase in Valuation Allowance		27,618			23,782			29,499
Write off Sec. 382 Limited Carryforwards		—			—			1,858
Stock Compensation		108			1,341			461
Research and Development Credit		(3,030	)		(3,091	)		(3,529	)
NC Tax Rate Change		8,359			—			—
Foreign Withholding Tax		925			1,410			—
Other		(172	)		294			(206	)
	$	925		$	1,410		$	—

Components of Tax Effects of Temporary Differences and Operating Loss Carryforwards Including Significant Portions of Deferred Tax Assets and Deferred Tax Liabilities

	Year ended December 31,
	2021			2020
Deferred tax assets
Accrued expenses	$	2,633		$	2,863
Operating lease liabilities		1,730			2,034
Stock compensation		9,037			7,147
R&D credits		16,995			13,965
Net operating loss carryforwards		108,489			85,842
Other		191			20
Deferred tax assets		139,075			111,871
Deferred tax liabilities
Operating lease assets		(1,548	)		(1,844	)
Other		(127	)		(245	)
Deferred tax liabilities		(1,675	)		(2,089	)
Valuation allowance		(137,400	)		(109,782	)
Net deferred tax assets	$	—		$	—

Summary of Changes in the Deferred Tax Valuation Allowance

The table below summarizes changes in the deferred tax valuation allowance (in thousands):

	2021			2020			2019
Balance at beginning of year	$	109,782		$	86,000		$	56,501
Charges to costs and expenses		35,961			25,170			31,357
Write-offs¹		(8,343	)		(1,388	)		(1,858	)
Balance at end of year	$	137,400		$	109,782		$	86,000
¹Includes impact of NC enacted tax rate change

Quarterly Results of Operations (Unaudited) (Tables)

12 Months Ended

Dec. 31, 2021

Quarterly Financial Information Disclosure [Abstract]

Quarterly Results of Operations

	Three Months Ended
	(unaudited)
	(in thousands, except share and per share amounts)
	March 31,			June 30,			September 30,			December 31,
	2021			2021			2021			2021
Total revenues	$	14,218		$	6,604		$	4,858		$	5,796
Total operating expenses		39,753			44,796			46,002			43,382
Loss from operations		(25,535	)		(38,192	)		(41,144	)		(37,586	)
Total other income (expense), net		(769	)		(1,010	)		(1,003	)		(2,188	)
Loss before income taxes		(26,304	)		(39,202	)		(42,147	)		(39,774	)
Income tax expense		138			220			321			246
Net loss	$	(26,442	)	$	(39,422	)	$	(42,468	)	$	(40,020	)
Net loss per share, basic and diluted	$	(0.65	)	$	(0.94	)	$	(1.00	)	$	(0.94	)
Weighted average common shares outstanding, basic and diluted		40,700,827			42,119,850			42,383,573			42,544,321


	March 31,			June 30,			September 30,			December 31,
	2020			2020			2020			2020
Total revenues	$	—		$	2,140		$	26,599		$	16,546
Total operating expenses		31,821			32,962			36,344			40,634
Loss from operations		(31,821	)		(30,822	)		(9,745	)		(24,088	)
Total other income (expense), net		798			(388	)		(998	)		(780	)
Loss before income taxes		(31,023	)		(31,210	)		(10,743	)		(24,868	)
Income tax expense		—			—			931			479
Net loss	$	(31,023	)	$	(31,210	)	$	(11,674	)	$	(25,347	)
Net loss per share, basic and diluted	$	(0.82	)	$	(0.83	)	$	(0.31	)	$	(0.67	)
Weighted average common shares outstanding, basic and diluted		37,659,722			37,786,208			38,009,204			38,053,609

Description of Business - Additional Information (Details)	1 Months Ended	12 Months Ended
	Sep. 30, 2020 USD ($)	Dec. 31, 2021 USD ($)	Feb. 21, 2022 Employee	Dec. 31, 2020 USD ($)
Description Of Business [Line Items]
Accumulated deficit		$ 584,459,000		$ 436,107,000
Cash and cash equivalents		$ 221,186,000		$ 207,306,000
Minimum
Description Of Business [Line Items]
Expected period to fund operations by existing cash resources		12 months
Simcere License Agreement
Description Of Business [Line Items]
Eligible to receive maximum development and commercial milestone payments		$ 156,000,000.0
Upfront payment received under agreement	$ 14,000,000.0
Received development and commercial milestone payments		8,000,000.0
EQRX License Agreement
Description Of Business [Line Items]
Upfront payments along with sales based royalties		26,000,000.0
Milestone payments		$ 330,000,000.0
Subsequent Event
Description Of Business [Line Items]
Number sales representatives hired \| Employee			34

Basis of Presentation and Summary of Significant Accounting Policies - Additional Information (Details) - USD ($)	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019	Nov. 30, 2018
Summary Of Significant Accounting Policies [Line Items]
Restricted cash	$ 400,000
Impairment charge of long-lived assets	0	$ 0	$ 0
Changes in valuation methodology	0	0
Loan payable	75,190,000	19,893,000
Unrecognized income tax benefits	0	0
Accrued income taxes	0	0
Patent \| Selling, General and Administrative Costs
Summary Of Significant Accounting Policies [Line Items]
Legal expenses	1,934,000	$ 2,761,000	$ 2,114,000
Significant Other Unobservable Inputs (Level 3)
Summary Of Significant Accounting Policies [Line Items]
Loan payable	75,200,000
Standby Letter of Credit \| Restricted Cash
Summary Of Significant Accounting Policies [Line Items]
Security deposit	$ 500,000			$ 500,000

Basis of Presentation and Summary of Significant Accounting Policies - Schedule of Property and Equipment Estimated Useful Lives (Details)	12 Months Ended
	Dec. 31, 2021
Computer Equipment
Property Plant And Equipment [Line Items]
Estimated useful lives	5 years
Laboratory Equipment
Property Plant And Equipment [Line Items]
Estimated useful lives	5 years
Furniture and Fixtures
Property Plant And Equipment [Line Items]
Estimated useful lives	7 years
Leasehold Improvements
Property Plant And Equipment [Line Items]
Estimated useful lives	7 years

Basis of Presentation and Summary of Significant Accounting Policies - Summary of Financials Instruments and Respective Fair Values (Details) - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
Assets
Assets at fair value	$ 110,443	$ 206,150
Money Market Funds
Assets
Assets at fair value	110,443	190,180
Certificates of Deposit
Assets
Assets at fair value		15,970
Quoted Prices in Active Markets for Identical Assets (Level 1)
Assets
Assets at fair value	110,443	206,150
Quoted Prices in Active Markets for Identical Assets (Level 1) \| Money Market Funds
Assets
Assets at fair value	$ 110,443	190,180
Quoted Prices in Active Markets for Identical Assets (Level 1) \| Certificates of Deposit
Assets
Assets at fair value		$ 15,970

Inventories - Schedule of Inventories (Details) $ in Thousands	Dec. 31, 2021 USD ($)
Inventory Disclosure [Abstract]
Raw materials	$ 2,105
Work in process	1,342
Finished goods	24
Inventories	$ 3,471

Property and Equipment - Schedule of Property and Equipment (Details) - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
Property Plant And Equipment [Line Items]
Accumulated depreciation	$ (1,296)	$ (827)
Property and equipment, net	2,013	2,482
Computer Equipment
Property Plant And Equipment [Line Items]
Property and equipment, gross	327	327
Laboratory Equipment
Property Plant And Equipment [Line Items]
Property and equipment, gross	334	334
Furniture and Fixtures
Property Plant And Equipment [Line Items]
Property and equipment, gross	866	866
Leasehold Improvements
Property Plant And Equipment [Line Items]
Property and equipment, gross	$ 1,782	$ 1,782

Property and Equipment - Additional Information (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
Property Plant And Equipment [Abstract]
Depreciation expenses relating to property and equipment	$ 469	$ 582	$ 356

Patent License Agreement - Additional Information (Details) - USD ($)	3 Months Ended	12 Months Ended			61 Months Ended
	Dec. 31, 2016	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019	Dec. 31, 2021
Patent License Agreement [Line Items]
Non-refundable license issue fee		$ 76,225,000	$ 73,271,000	$ 89,002,000
Milestone payments		$ 0			$ 600,000
University
Patent License Agreement [Line Items]
License agreement date		Nov. 23, 2016
License agreement amendment date		Mar. 24, 2017
Term of license agreement description		The term of the license agreement will continue until the later of (i) the expiration of the last valid claim within the patent rights covering the product in such country, (ii) the expiration of market exclusivity in such country and (iii) the 10th anniversary of the first commercial sale in such country. The University may terminate the agreement in the event (i) the Company fails to pay any amount or make any report when required to be made and fails to cure such failure within thirty (30) days after receipt of notice from the University, (ii) is in breach of any provision of the agreement and fails to remedy within forty-five (45) days after receipt of notice, (iii) makes a report to the University under the agreement that is determined to be materially false, (iv) declares insolvency or bankruptcy or (v) takes an action that causes patent rights or technical information to be subject to lien or encumbrance and fails to remedy any such breach with in forty-five (45) days of receipt of notice from the University. The Company may terminate the agreement at any time on written notice to the University at least ninety (90) days prior to the termination date specified in the notice. Upon expiration or termination of the agreement, all rights revert to the University.
License agreement termination notice period		90 days
University \| Maximum
Patent License Agreement [Line Items]
Milestone payments		$ 2,600,000
University \| License Revenue
Patent License Agreement [Line Items]
Non-refundable license issue fee	$ 500,000

Accrued Expenses - Schedule of Accrued Expenses (Details) - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
Payables And Accruals [Abstract]
Accrued external research	$ 773	$ 3,219
Accrued professional fees and other	8,058	3,920
Accrued external clinical study costs	9,579	5,683
Accrued compensation expense	4,770	3,664
Accrued expenses	$ 23,180	$ 16,486

Leases - Additional Information (Details) $ in Thousands				1 Months Ended	12 Months Ended
Leases - Additional Information (Details) $ in Thousands	Mar. 20, 2020	Jan. 27, 2016	Jan. 10, 2014	Nov. 30, 2018 USD ($) ft²	Dec. 31, 2021 USD ($)
Operating Leased Assets [Line Items]
Lease expiration date	May 31, 2020	Dec. 31, 2022	Jul. 31, 2017	Sep. 30, 2027
Renewal term		5 years		5 years
Laboratory and office space lease to secure \| ft²				60,000
Lease commencement date				Sep. 02, 2019
Cash payments for measurement of operating leases					$ 1,668
Standby Letter of Credit \| Restricted Cash
Operating Leased Assets [Line Items]
Security deposit				$ 500	$ 500

Leases - Summary of Lease Position and Weighted-Average Lease Term and Discount Rate of Operating Leases (Details) - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
Assets
Operating lease assets	$ 7,035	$ 8,026
Total lease assets	7,035
Liabilities
Current operating lease liabilities	$ 1,115
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List]	Other current liabilities
Non-current operating lease liabilities	$ 6,750	$ 7,865
Total lease liabilities	$ 7,865
Weighted-average remaining lease term (years)
Operating leases	5 years 8 months 12 days
Weighted-average discount rate
Operating leases	8.00%

Leases - Summary of Information Related to Lease Costs for Operating Leases (Details) - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
Operating Leased Assets [Line Items]
Total operating lease costs	$ 1,669	$ 2,146	$ 977
Research and Development
Operating Leased Assets [Line Items]
Operating lease costs	799	955	609
Selling, General and Administrative
Operating Leased Assets [Line Items]
Operating lease costs	$ 870	$ 1,191	$ 368

Leases - Reconciliation of Undiscounted Cash Flow to Operating Lease Liabilities (Details) $ in Thousands	Dec. 31, 2021 USD ($)
Leases [Abstract]
2022	$ 1,703
2023	1,634
2024	1,679
2025	1,725
2026	1,773
Thereafter	1,357
Total future minimum lease payments	9,871
Less: present value adjustment	(2,006)
Total operating lease liabilities	$ 7,865

Loan Payable - Additional Information (Details) - USD ($) $ in Millions		12 Months Ended
	Nov. 01, 2021	Dec. 31, 2021	May 29, 2020
Loan Agreement \| Hercules Capital, Inc.
Debt Instrument [Line Items]
Earliest maturity date		Jun. 01, 2022
Latest maturity date		Jan. 01, 2023
Debt instrument, maturity date		Jun. 01, 2025
Debt instrument maturity date description		following the interest only period, the Company will repay the principal balance and interest of the advances in equal monthly installments through June 1, 2024.
Interest rate description		greater of either (i) (a) the prime rate as reported in The Wall Street Journal, plus (b) 6.40%, and (ii) 9.65%.
Loan agreement, basis spread on variable rate		6.40%
Loan agreement, interest rate, stated percentage		9.65%
Prepayment fee description		3.0% of the prepayment amount in the first year; (b) 2.0% of the prepayment amount in the second year; and (c) 1.0% of the prepayment amount in the third year
Percentage of prepayment of loan amount for year first		3.00%
Percentage of prepayment of loan amount for year second		2.00%
Percentage of prepayment of loan amount for year third		1.00%
Percentage of loan amount prepayment charge		6.95%
Extinguishment of debt, amount		$ 0.2
Extinguishment of debt		Agreement as of November 1, 2021, including the unamortized debt issuance costs, and the fair value of the Second Amendment was recorded as a $0.2 million loss on extinguishment of debt for the twelve months ended December 31, 2021
Loan Agreement \| Hercules Capital, Inc. \| First Amendment to Loan and Security Agreement
Debt Instrument [Line Items]
Interest rate description		greater of either (i) (a) the prime rate as reported in The Wall Street Journal, plus (b) 6.20%, and (ii) 9.45%
Loan agreement, basis spread on variable rate		6.20%
Loan agreement, interest rate, stated percentage		9.45%
Loan Agreement \| Hercules Capital, Inc. \| First Tranche
Debt Instrument [Line Items]
Loan amount			$ 30.0
Remaining loan amount			20.0
End of term fee		$ 2.1
Percentage of aggregate amount of all loan advances payment		6.95%
Loan Agreement \| Hercules Capital, Inc. \| First Tranche \| Other Income (Expense)
Debt Instrument [Line Items]
Interest expense, loan agreement		$ 4.7
Loan Agreement \| Hercules Capital, Inc. \| First Tranche \| First Amendment to Loan and Security Agreement
Debt Instrument [Line Items]
Remaining loan amount		10.0
Loan Agreement \| Hercules Capital, Inc. \| Second Tranche
Debt Instrument [Line Items]
Loan amount			20.0
Loan Agreement \| Hercules Capital, Inc. \| Third Tranche
Debt Instrument [Line Items]
Loan amount			30.0
Loan Agreement \| Hercules Capital, Inc. \| Fourth Tranche
Debt Instrument [Line Items]
Loan amount			20.0
Loan Agreement \| Hercules Capital, Inc. \| Maximum
Debt Instrument [Line Items]
Loan amount			$ 100.0
Loan Agreement \| Hercules Capital, Inc. \| Minimum \| First Amendment to Loan and Security Agreement
Debt Instrument [Line Items]
Loan amount		$ 40.0
Second Amendment
Debt Instrument [Line Items]
Percentage of net product revenue		65.00%
Debt instrument minimum revenue of covenant market capitalization amount		$ 750.0
Debt instrument percentage of minimum revenue of covenant unrestricted cash		50.00%
Debt instrument percentage of unrestricted cash		100.00%
Second Amendment \| Hercules Capital, Inc.
Debt Instrument [Line Items]
Earliest maturity date	Dec. 01, 2024
Debt instrument, maturity date	Dec. 01, 2025
Debt instrument maturity date description		Following the interest only period, the Company will repay the principal balance and interest of the advances in equal monthly installments through November 1, 2026
Interest rate description		greater of either (i) (a) the prime rate as reported in The Wall Street Journal, plus (b) 5.90%, and (ii) 9.15%.
Loan agreement, basis spread on variable rate	5.90%
Loan agreement, interest rate, stated percentage	9.15%
Prepayment fee description		3.0% of the prepayment amount in the first year from the closing of the Second Amendment; (b) 2.0% of the prepayment amount in the second year from the closing of the Second Amendment; and (c) 1.0% of the prepayment amount in the third year
Percentage of prepayment of loan amount for year first	3.00%
Percentage of prepayment of loan amount for year second	2.00%
Percentage of prepayment of loan amount for year third	1.00%
Percentage of loan amount prepayment charge	6.75%
Second Amendment \| Hercules Capital, Inc. \| First Tranche
Debt Instrument [Line Items]
Loan amount	$ 100.0
Remaining loan amount	25.0
End of term fee	$ 2.1
Percentage of aggregate amount of all loan advances payment	6.75%
Debt instrument additional borrowing amount	$ 45.0
Second Amendment \| Hercules Capital, Inc. \| Second Tranche
Debt Instrument [Line Items]
Loan amount	20.0
Debt instrument available upon achievement of net product revenue	$ 50.0
Debt instrument trailing net product revenue	6 months
Second Amendment \| Hercules Capital, Inc. \| Third Tranche
Debt Instrument [Line Items]
Loan amount	$ 15.0
Second Amendment \| Hercules Capital, Inc. \| Fourth Tranche
Debt Instrument [Line Items]
Loan amount	15.0
Second Amendment \| Hercules Capital, Inc. \| Maximum
Debt Instrument [Line Items]
Loan amount	$ 150.0

Loan Payable - Schedule Future Principal Payments Due Under Loan Agreement Excluding Interest (Details) $ in Thousands	12 Months Ended
	Dec. 31, 2021 USD ($)
Debt Disclosure [Abstract]
2024	$ 2,860
2025	35,993
2026	36,147
Total principal outstanding	75,000
End of term charge	1,124
Unamortized debt discount and debt issuance costs	(934)
Total	$ 75,190

- Definition

Amount, after unamortized (discount) premium and debt issuance costs, of long-term debt. Includes, but not limited to, notes payable, bonds payable, debentures, mortgage loans and commercial paper. Excludes capital lease obligations.

+ References + Details

Stockholders' Equity - Additional Information (Details) - USD ($) $ / shares in Units, $ in Millions					1 Months Ended	12 Months Ended
	Feb. 23, 2022	Jul. 02, 2021	Jun. 15, 2018	May 22, 2017	Feb. 09, 2021	Dec. 31, 2021	Dec. 31, 2020
Class Of Stock [Line Items]
Common stock, par value						$ 0.0001	$ 0.0001
Common stock, shares authorized						120,000,000	120,000,000
Common stock, voting rights						Holders of common stock are entitled to one vote per share
Undesignated preferred stock, shares authorized to issue						5,000,000
Preferred stock, shares issued						0
Preferred stock, shares outstanding						0
IPO \| Convertible Preferred Stock
Class Of Stock [Line Items]
Conversion of outstanding preferred stock to common stock				18,933,053
Cowen And Company L L C \| At The Market Offerings
Class Of Stock [Line Items]
Maximum gross proceeds of common stock allowed from issuance and sell			$ 125.0
Proceeds from Issuance of Common Stock					$ 86.4
Cowen And Company L L C \| 2021 Sales Agreement
Class Of Stock [Line Items]
Maximum gross proceeds of common stock allowed from issuance and sell		$ 150.0
Cowen And Company L L C \| 2022 Sales Agreement \| Subsequent Event
Class Of Stock [Line Items]
Maximum gross proceeds of common stock allowed from issuance and sell	$ 300.0
Cowen And Company L L C \| Common Stock \| At The Market Offerings
Class Of Stock [Line Items]
Common stock, shares issued					3,513,027
Cowen And Company L L C \| Common Stock \| 2022 Sales Agreement \| Subsequent Event
Class Of Stock [Line Items]
Proceeds from Issuance of Common Stock	$ 100.0

Stockholders' Equity - Summary of Common Stock Shares Reserved for Future Issuance (Details) - shares	Dec. 31, 2021	Dec. 31, 2020
Class Of Stock [Line Items]
Common stock, shares reserved for future issuance	8,888,353	7,576,831
RSUs Outstanding
Class Of Stock [Line Items]
Common stock, shares reserved for future issuance	414,991
Options and RSUs available for grant under Equity Incentive Plans
Class Of Stock [Line Items]
Common stock, shares reserved for future issuance	1,771,635	932,051
Common Stock Options Outstanding
Class Of Stock [Line Items]
Common stock, shares reserved for future issuance	6,701,727	6,644,780

Stock-Based Compensation - Additional Information (Details) - USD ($) $ in Thousands		12 Months Ended
	Jan. 01, 2021	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019	Sep. 30, 2021	May 31, 2017	Mar. 31, 2011
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Stock-based compensation		$ 22,319	$ 18,770	$ 16,449
Employee Stock Options
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Stock options, maximum term		10 years
Stock-based compensation		$ 22,319	18,770	16,351
Unrecognized stock-based compensation costs		$ 33,500
Weighted-average recognition period		2 years 4 months 24 days
Non-employee Stock Options
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Stock-based compensation		$ 0	$ 0	$ 98
Restricted Stock Units (RSUs)
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Weighted-average recognition period		2 years 4 months 24 days
Unrecognized compensation cost		$ 5,200
2011 Equity Incentive Plan
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Number of shares approved for grant under equity incentive plan							4,400,640
Number of shares available for grant under equity incentive plan		0
2017 Equity Incentive Plan
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Number of shares approved for grant under equity incentive plan						1,932,000
Number of shares available for grant under equity incentive plan		1,307,735
Number of additional shares approved for grant under equity incentive plan	1,096,553
2021 Inducement Equity Incentive Plan
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Number of shares available for grant under equity incentive plan		68,900
2021 Inducement Equity Incentive Plan \| Maximum [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Number of shares approved for grant under equity incentive plan		500,000
2021 Sales Force Inducement Plan
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Number of shares available for grant under equity incentive plan		395,000
2021 Sales Force Inducement Plan \| Maximum [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Number of shares approved for grant under equity incentive plan					500,000

Stock-Based Compensation - Summary of Share-Based Compensation Expense Included in Statements of Operations (Details) - Employee and Non-employee Stock Options - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Total stock-based compensation expense	$ 22,319	$ 18,770	$ 16,449
Cost of Goods Sold
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Total stock-based compensation expense	252
Research and Development
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Total stock-based compensation expense	4,811	6,902	6,261
Selling, General and Administrative
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Total stock-based compensation expense	$ 17,256	$ 11,868	$ 10,188

Stock-Based Compensation - Fair Value of Stock Options Granted Using Black-Scholes Options Pricing Model (Details) - Employee and Non-employee Stock Options - $ / shares	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Expected volatility, minimum	76.80%	74.80%	74.20%
Expected volatility, maximum	79.60%	81.00%	82.10%
Weighted-average risk free rate, minimum	0.40%	0.30%	1.40%
Weighted-average risk free rate, maximum	1.30%	1.70%	2.60%
Expected term (in years)	6 years	6 years 7 days	6 years 7 days
Weighted-average grant-date fair value per share	$ 11.93	$ 12.17	$ 14.94

Stock-Based Compensation - Summary of Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Options outstanding
Beginning balance	6,644,780
Granted	2,168,053
Cancelled	(1,176,075)
Exercised	(935,031)
Ending balance	6,701,727	6,644,780
Exercisable	3,660,578
Vested and expected to vest	6,701,727
Weighted average exercise price
Beginning balance	$ 16.91
Granted	17.77
Cancelled	21.40
Exercised	6.25
Ending balance	17.88	$ 16.91
Exercisable	16.72
Vested and expected to vest	$ 17.88
Weighted average, Remaining contractual for life (Years)
Balance	7 years 2 months 12 days	7 years 3 months 18 days
Exercisable	5 years 10 months 24 days
Vested and expected to vest	7 years 2 months 12 days
Weighted average, Aggregate intrinsic value
Balance	$ 10,427	$ 35,464
Exercisable	10,422
Vested and expected to vest	$ 10,427

Stock-Based Compensation - Summary of Restricted Stock Units Activity (Details) - Restricted Stock Units (RSUs)	12 Months Ended
	Dec. 31, 2021 $ / shares shares
Number of RSUs
Granted \| shares	507,906
Cancelled \| shares	(92,915)
Ending balance \| shares	414,991
Weighted-Average Fair Value per Share
Granted \| $ / shares	$ 18.20
Cancelled \| $ / shares	18.07
Ending balance \| $ / shares	$ 18.24

License Revenue - Additional Information (Details) - USD ($)					12 Months Ended
	Aug. 03, 2020	Jul. 22, 2020	Jun. 15, 2020	May 22, 2020	Dec. 31, 2021
ARC Therapeutics, LLC
Revenue Recognition Multiple Deliverable Arrangements [Line Items]
Upfront payment received				$ 1,000,000.0
Percentage of equity interest received as consideration				10.00%
Value of equity interest received				$ 1,100,000
Milestone payments receivable				2,000,000.0
License revenue recognized				$ 2,100,000	$ 0
Equity interest				10.00%
Genor Biopharma Co. Inc.
Revenue Recognition Multiple Deliverable Arrangements [Line Items]
Non-refundable, upfront payment			$ 6,000,000.0
Milestone payments receivable			40,000,000.0
License revenue recognized			$ 6,000,000.0		3,000,000.0
EQRx Inc.
Revenue Recognition Multiple Deliverable Arrangements [Line Items]
Upfront payment received		$ 20,000,000.0
Milestone payments receivable		290,000,000.0
License revenue recognized		$ 20,000,000.0			4,800,000
Typical payment terms on invoice payment		30 days
Number of days due from invoice date		30 days
Manufacturing costs					2,500,000
Nanjing Simcere Dongyuan Pharmaceutical Co., Ltd
Revenue Recognition Multiple Deliverable Arrangements [Line Items]
Upfront payment received	$ 14,000,000.0				14,000,000.0
Milestone payments receivable	156,000,000.0
License revenue recognized					8,000,000.0
Manufacturing costs					1,000,000.0
Withholding taxes	$ 1,400,000				$ 800,000

Net Loss Per Common Share - Schedule of Potentially Dilutive Securities Excluded from Computations of Diluted Weighted-average Shares Outstanding (Details) - shares	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]
Total potential diluted shares	7,507,883	6,576,688	5,443,730
Stock Options Issued and Outstanding
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]
Total potential diluted shares	7,056,745	6,576,688	5,443,730
Restricted Stock Units (RSUs)
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]
Total potential diluted shares	451,138

Income Taxes - Additional Information (Details) - USD ($)	1 Months Ended		12 Months Ended
	Nov. 18, 2021	Apr. 30, 2019	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
Income Taxes [Line Items]
Unrecognized income tax benefits			$ 0	$ 0
Unrecognized income tax benefits impact on effective income tax rate			0	0
Accrued income taxes			$ 0	$ 0
U.S. statutory income tax rate			21.00%	21.00%	21.00%
Valuation allowance			$ 137,400,000	$ 109,782,000
Increase in deferred tax assets valuation allowance			27,600,000
Federal research and development credit carryforwards			16,995,000	$ 13,965,000
Federal
Income Taxes [Line Items]
Net operating loss carryforwards			$ 510,000,000.0
Net operating loss carryforwards expiration year			2029
Net operating loss carryforwards expire in 2029			$ 95,400,000
Net operating loss carryforwards indefinite expiration period			414,600,000
Federal research and development credit carryforwards			17,000,000.0
Operating loss carryforwards limitation		$ 8,000,000.0
State
Income Taxes [Line Items]
Net operating loss carryforwards			$ 332,700,000
Net operating loss carryforwards expiration year			2024
Operating loss carryforwards limitation		1,200,000
Research and Development (R&D) Credit Carryforwards
Income Taxes [Line Items]
Tax credit carryforwards limitation		$ 100,000
Research and Development (R&D) Credit Carryforwards \| Federal
Income Taxes [Line Items]
Expiration year for tax credit carryforwards			2035
North Carolina
Income Taxes [Line Items]
Corporate income tax rate current	2.50%
Decrease in corporate income tax rate by 2030	0.00%
Reduction in value of deferred tax assets resulted in tax expense	$ 8,400,000
Benefits expected to be realized from deferred tax assets	0
Reduction in deferred tax assets including non-operating loss	$ 0

Income Taxes - Components of Income Tax Expense (Benefit) Attributable to Continuing Operations (Details) - USD ($)	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020
Current Expense:
Foreign	$ 925	$ 1,410
Total current expense	925	1,410
Deferred Expense:
Total deferred expense	$ 925	$ 1,410

Income Taxes - Summary of Differences Between the Income Tax Expense Attributable to Continuing Operations and the Expense Computed at U.S. Statutory Income Tax Rate (Details) - USD ($) $ in Thousands	3 Months Ended						12 Months Ended
	Dec. 31, 2021	Sep. 30, 2021	Jun. 30, 2021	Mar. 31, 2021	Dec. 31, 2020	Sep. 30, 2020	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
Income Tax Disclosure [Abstract]
Federal income tax benefit at statutory rate:							$ (30,960)	$ (20,547)	$ (25,714)
Increase (reduction) in income tax resulting from:
State Income Taxes							(1,923)	(1,779)	(2,369)
Increase in Valuation Allowance							27,618	23,782	29,499
Write off Sec. 382 Limited Carryforwards									1,858
Stock Compensation							108	1,341	461
Research and Development Credit							(3,030)	(3,091)	(3,529)
NC Tax Rate Change							8,359
Foreign Withholding Tax							925	1,410
Other							(172)	294	$ (206)
Income tax expense (benefit)	$ 246	$ 321	$ 220	$ 138	$ 479	$ 931	$ 925	$ 1,410

Income Taxes - Components of Tax Effects of Temporary Differences and Operating Loss Carryforwards Including Significant Portions of Deferred Tax Assets and Deferred Tax Liabilities (Details) - USD ($) $ in Thousands	Dec. 31, 2021	Dec. 31, 2020
Deferred tax assets
Accrued expenses	$ 2,633	$ 2,863
Operating lease liabilities	1,730	2,034
Stock compensation	9,037	7,147
R&D credits	16,995	13,965
Net operating loss carryforwards	108,489	85,842
Other	191	20
Deferred tax assets	139,075	111,871
Deferred tax liabilities
Operating lease assets	(1,548)	(1,844)
Other	(127)	(245)
Deferred tax liabilities	(1,675)	(2,089)
Valuation allowance	$ (137,400)	$ (109,782)

Income Taxes - Summary of Changes in the Deferred Tax Valuation Allowance (Details) - Valuation Allowance of Deferred Tax Assets - USD ($) $ in Thousands	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
Valuation Allowance [Line Items]
Balance at beginning of year	$ 109,782	$ 86,000	$ 56,501
Charges to costs and expenses	35,961	25,170	31,357
Write-offs	(8,343)	(1,388)	(1,858)
Balance at end of year	$ 137,400	$ 109,782	$ 86,000

Related Party Transactions - Additional Information (Details) - Chairman of the Board of Directors - USD ($)	12 Months Ended
	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
Scientific Advisory
Related Party Transaction [Line Items]
Consulting fees	$ 3,000	$ 6,000	$ 6,000
Consulting agreement expiration date	Jun. 30, 2021
Scientific Clinical and Regulatory Advisory
Related Party Transaction [Line Items]
Consulting agreement expiration date	Jun. 30, 2022
Service payment	$ 50,000
Accrued payment	25,000
Senior Advisor Agreement
Related Party Transaction [Line Items]
Service payment	$ 200,000
Agreement expiration date	Dec. 31, 2023

Quarterly Financial Information (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended								12 Months Ended
	Dec. 31, 2021	Sep. 30, 2021	Jun. 30, 2021	Mar. 31, 2021	Dec. 31, 2020	Sep. 30, 2020	Jun. 30, 2020	Mar. 31, 2020	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019
Quarterly Financial Information Disclosure [Abstract]
Total revenues	$ 5,796	$ 4,858	$ 6,604	$ 14,218	$ 16,546	$ 26,599	$ 2,140		$ 31,476	$ 45,285
Total operating expenses	43,382	46,002	44,796	39,753	40,634	36,344	32,962	$ 31,821	173,933	141,761	$ 129,041
Loss from operations	(37,586)	(41,144)	(38,192)	(25,535)	(24,088)	(9,745)	(30,822)	(31,821)	(142,457)	(96,476)	(129,041)
Total other income (expense), net	(2,188)	(1,003)	(1,010)	(769)	(780)	(998)	(388)	798	(4,970)	(1,368)	6,594
Loss before income taxes	(39,774)	(42,147)	(39,202)	(26,304)	(24,868)	(10,743)	(31,210)	(31,023)	(147,427)	(97,844)	(122,447)
Income tax expense	246	321	220	138	479	931			925	1,410
Net loss	$ (40,020)	$ (42,468)	$ (39,422)	$ (26,442)	$ (25,347)	$ (11,674)	$ (31,210)	$ (31,023)	$ (148,352)	$ (99,254)	$ (122,447)
Net loss per share, basic and diluted	$ (0.94)	$ (1.00)	$ (0.94)	$ (0.65)	$ (0.67)	$ (0.31)	$ (0.83)	$ (0.82)	$ (3.54)	$ (2.62)	$ (3.27)
Weighted average common shares outstanding, basic and diluted	42,544,321	42,383,573	42,119,850	40,700,827	38,053,609	38,009,204	37,786,208	37,659,722	41,943,417	37,878,026	37,499,256