Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Mar. 31, 2022 | Jun. 30, 2021 | |
Document and Entity Information | |||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2021 | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Entity File Number | 001-31918 | ||
Entity Registrant Name | IDERA PHARMACEUTICALS, INC. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 04-3072298 | ||
Entity Address, Address Line One | 505 Eagleview Blvd., Suite 212 | ||
Entity Address, City or Town | Exton | ||
Entity Address, State or Province | PA | ||
Entity Address, Postal Zip Code | 19341 | ||
City Area Code | 484 | ||
Local Phone Number | 348-1600 | ||
Title of 12(b) Security | Common Stock, $.001 par value | ||
Trading Symbol | IDRA | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
ICFR Auditor Attestation Flag | false | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Common Stock, Shares Outstanding | 52,924,870 | ||
Entity Public Float | $ 63.8 | ||
Entity Central Index Key | 0000861838 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2021 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false | ||
Auditor Firm ID | 42 | ||
Auditor Name | ERNST & YOUNG LLP | ||
Auditor Location | Philadelphia, Pennsylvania |
BALANCE SHEETS
BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 32,545 | $ 33,229 |
Short-term investments | 4,499 | |
Prepaid expenses and other current assets | 1,493 | 3,627 |
Total current assets | 34,038 | 41,355 |
Property and equipment, net | 22 | 44 |
Operating lease right-of-use assets | 734 | 930 |
Other assets | 70 | 70 |
Total assets | 34,864 | 42,399 |
Current liabilities: | ||
Accounts payable | 565 | 329 |
Accrued expenses | 4,088 | 6,072 |
Operating lease liability | 209 | 191 |
Other current liability | 0 | 435 |
Total current liabilities | 4,862 | 7,027 |
Warrant liability, long-term | 6,983 | |
Future tranche right liability, long-term | 118,803 | |
Operating lease liability, net of current portion | 549 | 758 |
Total liabilities | 5,411 | 133,571 |
Commitments and contingencies (Note 12) | ||
Stockholders' equity (deficit): | ||
Common stock, $0.001 par value, Authorized - 140,000 shares; Issued and outstanding - 52,818 and 38,291 at December 31, 2021 and December 31, 2020, respectively | 53 | 38 |
Additional paid-in capital | 764,861 | 742,342 |
Accumulated deficit | (735,461) | (833,552) |
Total stockholders' deficit | 29,453 | (91,172) |
Total liabilities and stockholders' deficit | 34,864 | 42,399 |
Series B1 Redeemable Convertible Preferred Stock | ||
TEMPORARY EQUITY | ||
Preferred stock | ||
Series A Preferred Stock [Member] | ||
Stockholders' equity (deficit): | ||
Preferred stock |
BALANCE SHEETS (Parenthetical)
BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2021 | Dec. 31, 2020 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 140,000,000 | 140,000,000 |
Common stock, shares issued | 52,818,000 | 38,291,000 |
Common stock, shares outstanding | 52,818,000 | 38,291,000 |
Series B1 Redeemable Convertible Preferred Stock | ||
Preferred stock, par value | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares designated | 277,921 | 278,000 |
Preferred stock, shares issued | 0 | 24,000 |
Preferred stock, shares outstanding | 0 | 24,000 |
Common stock, shares outstanding | 24,000 | |
Series A Preferred Stock [Member] | ||
Preferred stock, par value | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares designated | 1,500,000 | 1,500,000 |
Preferred stock, shares issued | 1,000 | 1,000 |
Preferred stock, shares outstanding | 655 | 655 |
STATEMENTS OF OPERATIONS
STATEMENTS OF OPERATIONS - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
STATEMENTS OF OPERATIONS | |||
Alliance revenue | $ 1,448 | ||
Revenue, Product and Service [Extensible List] | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember |
Operating expenses: | |||
Research and development | $ 16,375 | $ 24,772 | $ 34,853 |
General and administrative | 9,976 | 11,915 | 12,481 |
Restructuring costs | 1,322 | 181 | |
Total operating expenses | 27,673 | 36,687 | 47,515 |
Loss from operations | (27,673) | (36,687) | (46,067) |
Other income (expense): | |||
Interest income | 9 | 165 | 1,150 |
Interest expense | (7) | (3) | |
Warrant revaluation gain (loss) | 6,983 | (3,742) | (598) |
Future tranche right revaluation gain (loss) | 118,803 | (72,367) | (10,964) |
Foreign currency exchange loss | (24) | (28) | (36) |
Net income / (loss) | 98,091 | (112,662) | (56,515) |
Deemed dividend on preferred stock related to December 2019 Private Placement (see Note 7) | (28,043) | ||
Undistributed earnings to preferred stockholders | (1,150) | ||
Net income (loss) applicable to common stockholders | 96,941 | (112,662) | (84,558) |
Net income (loss) applicable to common stockholders (Note 16) | |||
Net income (loss) | 96,941 | (112,662) | (84,558) |
Diluted | $ (28,845) | $ (112,662) | $ (84,558) |
Net income (loss) per share applicable to common stockholders (Note 16) | |||
Basic | $ 1.97 | $ (3.33) | $ (2.96) |
Diluted | $ (0.58) | $ (3.33) | $ (2.96) |
Weighted-average number of common shares used in computing net income (loss) per share applicable to common stockholders | |||
Basic | 49,203 | 33,821 | 28,545 |
Diluted | 50,127 | 33,821 | 28,545 |
STATEMENTS OF REDEEMABLE PREFER
STATEMENTS OF REDEEMABLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT) - USD ($) $ in Thousands | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Series B1 Redeemable Convertible Preferred Stock | Total |
Beginning balance at Dec. 31, 2018 | $ 27 | $ 728,342 | $ (664,375) | $ 63,994 | |
Beginning balance (in shares) at Dec. 31, 2018 | 27,188,000 | ||||
Sale of redeemable convertible preferred stock | 24,000 | ||||
Sale of common stock, net of issuance costs | $ 3 | 5,295 | 5,298 | ||
Sale of common stock, net of issuance costs (in shares) | 2,068,000 | ||||
Deemed dividend related to December 2019 Private Placement (Note 7) | (28,043) | (28,043) | |||
Issuance of commitment shares (in shares) | 270,000 | ||||
Issuance of common stock under employee stock purchase plan | 121 | 121 | |||
Issuance of common stock under employee stock purchase plan (in shares) | 61,000 | ||||
Issuance of common stock upon exercise of common stock options and warrants | 3 | 3 | |||
Issuance of common stock upon exercise of common stock options and warrants (in shares) | 38,000 | ||||
Issuance of common stock for services rendered | 129 | 129 | |||
Issuance of common stock for services rendered (in shares) | 47,000 | ||||
Stock-based compensation expense | 3,845 | 3,845 | |||
Net income (loss) | (56,515) | (56,515) | |||
Ending balance at Dec. 31, 2019 | $ 30 | 709,692 | (720,890) | (11,168) | |
Ending balance (in shares) at Dec. 31, 2019 | 29,672,000 | 24,000 | |||
Sale of common stock, net of issuance costs | $ 8 | 28,638 | 28,646 | ||
Sale of common stock, net of issuance costs (in shares) | 8,218,000 | ||||
Issuance of common stock under equity incentive plan (vesting of restricted stock units (in shares) | 177,000 | ||||
Issuance of common stock under employee stock purchase plan | 113 | 113 | |||
Issuance of common stock under employee stock purchase plan (in shares) | 76,000 | ||||
Issuance of common stock upon exercise of common stock options and warrants | 15 | 15 | |||
Issuance of common stock upon exercise of common stock options and warrants (in shares) | 5,000 | ||||
Issuance of common stock for services rendered | 243 | 243 | |||
Issuance of common stock for services rendered (in shares) | 143,000 | ||||
Stock-based compensation expense | 3,641 | 3,641 | |||
Net income (loss) | (112,662) | (112,662) | |||
Ending balance at Dec. 31, 2020 | $ 38 | 742,342 | (833,552) | $ (91,172) | |
Ending balance (in shares) at Dec. 31, 2020 | 38,291,000 | 24,000 | 38,291,000 | ||
Sale of common stock, net of issuance costs | $ 6 | 19,509 | $ 19,515 | ||
Sale of common stock, net of issuance costs (in shares) | 5,918,000 | ||||
Issuance of common stock under equity incentive plan (vesting of restricted stock units (in shares) | 237,000 | ||||
Issuance of common stock under employee stock purchase plan | 59 | 59 | |||
Issuance of common stock under employee stock purchase plan (in shares) | 49,000 | ||||
Issuance of common stock upon exercise of common stock options and warrants | $ 7 | 264 | 271 | ||
Issuance of common stock upon exercise of common stock options and warrants (in shares) | 5,871,000 | ||||
Issuance of common stock for services rendered | 152 | 152 | |||
Issuance of common stock for services rendered (in shares) | 84,000 | ||||
Stock-based compensation expense | 2,537 | 2,537 | |||
Conversion of Series B1 preferred stock | $ 2 | (2) | |||
Conversion of Series B1 preferred stock (in shares) | 2,368,000 | (23,684) | |||
Net income (loss) | 98,091 | 98,091 | |||
Ending balance at Dec. 31, 2021 | $ 53 | $ 764,861 | $ (735,461) | $ 29,453 | |
Ending balance (in shares) at Dec. 31, 2021 | 52,818,000 | 52,818,000 |
STATEMENTS OF CASH FLOWS
STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Cash Flows from Operating Activities: | |||
Net income (loss) | $ 98,091 | $ (112,662) | $ (56,515) |
Adjustments to reconcile net income (loss) to net cash used in operating activities: | |||
Stock-based compensation | 2,537 | 3,641 | 3,845 |
Warrant liability revaluation loss (gain) | (6,983) | 3,742 | 598 |
Future tranche right liability revaluation (gain) loss | (118,803) | 72,367 | 10,964 |
Issuance of common stock for services rendered | 152 | 243 | 129 |
Accretion of discounts on short-term investments | (1) | (46) | (372) |
Depreciation and amortization expense | 22 | 61 | 120 |
(Gain) loss on disposal of property and equipment | (10) | ||
Changes in operating assets and liabilities: | |||
Prepaid expenses and other assets | 2,134 | 500 | (2,160) |
Accounts payable, accrued expenses, and other liabilities | (1,751) | (1,629) | (1,105) |
Other | 5 | 11 | 8 |
Net cash used in operating activities | (24,597) | (33,772) | (44,498) |
Cash Flows from Investing Activities: | |||
Purchases of available-for-sale securities | (12,178) | (44,502) | |
Proceeds from maturity of available-for-sale securities | 4,500 | 10,499 | 42,100 |
Proceeds from the sale of property and equipment | 11 | ||
Purchases of property and equipment | (8) | (11) | |
Net cash (used in) provided by investing activities | 4,500 | (1,687) | (2,402) |
Cash Flows from Financing Activities: | |||
Proceeds from private placement | 10,072 | ||
Proceeds from common stock financings, net | 19,518 | 28,758 | 5,298 |
Proceeds from employee stock purchases | 59 | 113 | 121 |
Proceeds from exercise of common stock options and warrants | 271 | 15 | 3 |
Payments on note payable and seller-financed purchases | (435) | (217) | |
Other | (6) | ||
Net cash provided by financing activities | 19,413 | 28,669 | 15,488 |
Net decrease in cash and cash equivalents | (684) | (6,790) | (31,412) |
Cash and cash equivalent, beginning of period | 33,229 | 40,019 | 71,431 |
Cash and cash equivalents, end of period | 32,545 | 33,229 | 40,019 |
Supplemental disclosure of cash flow information: | |||
Cash paid for interest | 5 | 3 | |
Increase to operating lease right-of-use asset upon adoption of ASC 842 | 1,236 | ||
Increase to operating lease right-of-use assets upon acquisition | 54 | ||
Increase to operating lease liability upon adoption of ASC 842 | 1,236 | ||
Increase to operating lease liability upon acquisition | 54 | ||
Supplemental disclosure of non-cash financing and investing activities: | |||
Offering costs in accounts payable and accrued expenses | $ 3 | 112 | $ 165 |
Non-cash seller-financed purchases | $ 652 |
Business and Organization
Business and Organization | 12 Months Ended |
Dec. 31, 2021 | |
Business and Organization | |
Business and Organization | Note 1. Business and Organization Business Overview Idera Pharmaceuticals, Inc. (“Idera” or the “Company”), a Delaware corporation, is a biopharmaceutical company with a business strategy focused on the clinical development, and ultimately the commercialization, of drug candidates for rare disease indications characterized by small, well-defined patient populations with serious unmet medical needs. The Company’s current focus is to identify and potentially acquire rights to novel development or commercial stage rare disease programs, through new business development opportunities, including additional strategic alternatives. The Company has in the past and may in the future explore collaborative alliances to support development and commercialization of any of our drug candidates. Until May 2021, the Company was developing tilsotolimod, via intratumoral injection, for the treatment of anti-PD1 refractory metastatic melanoma in combination with ipilimumab, an anti-CTLA4 antibody marketed as Yervoy® by Bristol Myers Squibb Company (“BMS”) in a Phase 3 registration trial. During the first quarter of 2021, the Company announced that ILLUMINATE-301, its pivotal registration trial of tilsotolimod in combination with ipilimumab versus ipilimumab alone in patients with anti-PD-1 refractory advanced melanoma, did not meet its primary endpoint of Objective Response Rate (“ORR”). Based on subsequent evaluation of the full data set, in May 2021, the Company announced that it would not continue the trial to its Overall Survival (“OS”) primary endpoint. Through December 2021, the Company was also evaluating intratumoral tilsotolimod in combination with nivolumab, an anti-PD1 antibody marketed as Opdivo® by BMS, and ipilimumab for the treatment of multiple solid tumors in a multicohort Phase 2 trial. In December 2021, the Company announced that preliminary data from the second 10 patients dosed in the safety cohort of ILLUMINATE-206 showed a safety profile consistent with the first 10 patients in ILLUMINATE-206 and with prior studies. No further enrollment in ILLUMINATE-206 is planned at this time. The Company believes that while the clinical trials with tilsotolimod have not yet translated into a new treatment alternative for patients, data supporting tilsotolimod’s mechanism of action and encouraging safety profile from across the array of pre-clinical and clinical work to date, together with its intellectual property protection, are noteworthy. As a result, in December 2021, the Company announced that it will consider an out-licensing arrangement so that tilsotolimid’s full potential may continue to be explored on behalf of patients who do not respond to traditional immunotherapy. Reduction-in-Force In April 2021, following the announcement that the Company’s ILLUMINATE-301 trial did not meet its primary endpoint of ORR, the Company implemented a reduction-in-force which affected approximately 50% of its workforce through September 30, 2021. The Company eliminated 17 positions primarily in the area of research and development. The decision was made in order to align the Company’s workforce with its needs in light of the outcome of ILLUMINATE-301’s ORR endpoint, its ongoing ILLUMINATE development program and other business development activities focused on identifying new portfolio opportunities. In connection with these actions, the Company incurred and paid termination costs for the reduction in workforce, which includes severance, benefits and related costs, of approximately $1.3 million during the year ended December 31, 2021. Note 1. Business and Organization (Continued) Nasdaq Compliance As previously disclosed, on November 26, 2021, we received a deficiency letter (the “Nasdaq Letter”) from the Nasdaq Listing Qualifications Department, notifying us that the Company is not in compliance with Nasdaq Listing Rule 5550(a)(2), which requires the Company to maintain a minimum bid price of at least $1 per share for continued listing on The Nasdaq Capital Market (the “Minimum Bid Requirement”). The Company’s failure to comply with the Minimum Bid Requirement was based on the Company’s common stock per share price being below the $1 threshold for a period of 30 consecutive business days. In accordance with Nasdaq Listing Rule 5810(c)(3)(A) (the “Compliance Period Rule”), the Company has been provided an initial period of 180 calendar days (the “Compliance Date”), to regain compliance with the Minimum Bid Requirement. If, at any time before the Compliance Date, the bid price for the Company’s common stock closes at $1.00 or more per share for a minimum of 10 consecutive business days, as required under Nasdaq requirements, the Staff will provide written notification to the Company that it complies with the Minimum Bid Requirement, unless the Staff exercises its discretion to extend this 10-day period pursuant to Nasdaq Listing Rule 5810(c)(3)(H). If the Company does not regain compliance with the Minimum Bid Requirement by the Compliance Date, the Company may be eligible for an additional 180 calendar day compliance period (the “Second Compliance Period”). To qualify, the Company would need to meet the continued listing requirement for the market value of publicly held shares and all other initial listing standards of the Nasdaq Capital Market, with the exception of the Minimum Bid Requirement, and provide written notice to the Staff of its intention to cure the deficiency during the Second Compliance Period. Neither the Nasdaq Letter nor the Company’s noncompliance with the Minimum Bid Requirement have an immediate effect on the listing or trading of the Company’s common stock, which continue to trade on The Nasdaq Capital Market under the symbol “IDRA.” Liquidity and Financial Condition As of December 31, 2021, the Company had an accumulated deficit of $735.5 million and a cash and cash equivalents balance of $32.5 million. The Company expects to incur substantial operating losses in future periods and will require additional capital as it seeks to advance any future drug candidates through development to commercialization. The Company does not expect to generate product revenue, sales-based milestones, or royalties until the Company successfully completes development of and obtains marketing approval for any future drug candidates, either alone or in collaboration with third parties, which the Company expects will take a number of years, if at all. To commercialize any future drug candidates, the Company needs to complete clinical development and comply with comprehensive regulatory requirements. The Company is subject to a number of risks and uncertainties similar to those of other companies of the same size within the biotechnology industry, such as uncertainty of clinical trial outcomes, uncertainty of additional funding, and history of operating losses. The Company follows the provisions of Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 205-40, Presentation of Financial Statements—Going Concern |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2021 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | Note 2. Summary of Significant Accounting Policies Basis of Presentation The accompanying financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”). Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates, judgements, and assumptions that affect the reported amounts of assets, liabilities, equity, revenues and expenses, and related disclosure of contingencies in the accompanying financial statements and these notes. In addition, management’s assessment of the Company’s ability to continue as a going concern involves the estimation of the amount and timing of future cash inflows and outflows. On an ongoing basis, the Company evaluates its estimates, judgments and methodologies. The Company bases its estimates on historical experience and on various other assumptions that are believed to be reasonable. Actual results could differ materially from those estimates. Segment Information Operating segments are defined as components of an enterprise in which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and assessing performance. The Company views its operations and manages its business as one operating segment, which is the business of developing novel therapeutics for rare diseases and oncology. Financial Instruments The fair value of the Company’s financial instruments is determined and disclosed in accordance with the three-tier fair value hierarchy specified in Note 3. The Company is required to disclose the estimated fair values of its financial instruments. As of December 31, 2021, the Company’s financial instruments consisted of cash and cash equivalents. As of December 31, 2020, the Company’s financial instruments consisted of cash, cash equivalents, short-term investments, and warrant and future tranche right liabilities. The estimated fair values of these financial instruments approximate their carrying values as of December 31, 2021 and 2020. As of December 31, 2021, the Company did not have any other derivatives, hedging instruments or other similar financial instruments. Concentration of Credit Risk Financial instruments that subject the Company to credit risk primarily consist of cash, cash equivalents and short-term investments. The Company’s credit risk is managed by investing in highly rated money market instruments, U.S. treasury bills, corporate bonds, commercial paper and/or other debt securities. Due to these factors, no significant additional credit risk is believed by management to be inherent in the Company’s assets. As of December 31, 2021, all of the Company’s cash and cash equivalents were held at two financial institutions. Cash and Cash Equivalents The Company considers all highly liquid investments with maturities of 90 days or less when purchased to be “cash equivalents.” Cash and cash equivalents at December 31, 2021 consisted of cash and money market funds. Cash and cash equivalents at December 31, 2020 consisted of cash and cash equivalents and short-term investments. Note 2. Summary of Significant Accounting Policies (Continued) Property and Equipment Property and equipment are carried at acquisition cost less accumulated depreciation, subject to review for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable as described further under the heading "Impairment of Long-Lived Assets" below. The cost of normal, recurring, or periodic repairs and maintenance activities related to property and equipment are expensed as incurred. The cost for planned major maintenance activities, including the related acquisition or construction of assets, is capitalized if the repair will result in future economic benefits. Depreciation and amortization are computed using the straight-line method based on the estimated useful lives of the related assets. Leasehold improvements are amortized over the remaining lease term or the related useful life, if shorter. Equipment and other long-lived assets are depreciated over three When an asset is disposed of, the associated cost and accumulated depreciation is removed from the related accounts on the Company's balance sheet with any resulting gain or loss included in the Company's statement of operations. Operating Lease Right-of-use Asset and Lease Liability The Company accounts for leases under ASC 842, Leases Property, Plant, and Equipment As of December 31, 2021 and 2020, the Company’s operating lease ROU assets and corresponding short-term and long-term lease liabilities primarily relate to its existing Exton, Pennsylvania facility operating lease, which expires on May 31, 2025. Impairment of Long-Lived Assets In accordance with ASC 360-10-35, Impairment or Disposal of Long-Lived Assets Note 2. Summary of Significant Accounting Policies (Continued) Other Current Liability In October 2020, the Company entered into a short-term financing arrangement with a third-party vendor to finance insurance premiums. The aggregate amount financed under this agreement was Warrant Liability The Company accounts for stock warrants as either equity instruments, liabilities or derivative liabilities in accordance with ASC 480, Distinguishing Liabilities from Equity Derivatives and Hedging Future Tranche Right Liability On December 23, 2019, the Company entered into a Securities Purchase Agreement (the “December 2019 Securities Purchase Agreement”) with institutional investors affiliated with Baker Brothers (the “Purchasers”), an existing stockholder and related party (see Note 15). As more fully described in Note 7, the December 2019 Securities Purchase Agreement contained call options on redeemable preferred shares with warrants (conditionally exercisable for shares that are puttable). The Company determined that these call options represent freestanding financial instruments and accounts for the options as liabilities (“Future Tranche Right Liability”) under ASC 480, which requires the measurement and recognition of the fair value of the liability at the time of issuance and at each reporting period. Any change in fair value is recognized in Future Tranche Right Liability Revaluation (Loss) Gain in the Company’s statements of operations. As of December 31, 2020, the Future Tranche Right Liability was classified as a long-term liability in the Company’s balance sheet as settlement is in the form of the applicable Series B convertible preferred stock and warrants exercisable for shares of either Series B1 Preferred Stock or the Company’s common stock. During the three months ended March 31, 2021, the liability-classified call options provided for under the December 2019 Securities Purchase Agreement terminated and, accordingly, the liability balance was derecognized. For additional discussion on the Future Tranche Right Liability, see Note 7. Preferred Stock The Company applies ASC 480 when determining the classification and measurement of its preferred stock. Preferred shares subject to mandatory redemption are classified as liability instruments and are measured at fair value. Conditionally redeemable preferred shares (including preferred shares that feature redemption rights that are either within the control of the holder or subject to redemption upon the occurrence of uncertain events not solely within the Company’s control) are classified as temporary equity. At all other times, preferred shares are classified as stockholders’ equity. Accretion of redeemable convertible preferred stock includes the accretion of the Company's Series B redeemable convertible preferred stock to its stated value. The carrying value of the Series B redeemable convertible preferred stock is being accreted to redemption value using the effective interest method, from the date of issuance to the earliest date the holders can demand redemption or until the redeemable convertible preferred stock ceases to be outstanding. Note 2. Summary of Significant Accounting Policies (Continued) Redeemable Preferred Stock Issued with Other Freestanding Instruments The Company considers guidance within ASC 470-20, Debt Revenue Recognition The Company recognizes revenue in accordance with ASC 606, Revenue from Contracts with Customers (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it determines that it is probable it will collect the consideration to which it is entitled in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Amounts received prior to satisfying the revenue recognition criteria are recognized as deferred revenue in the Company’s balance sheet. Amounts expected to be recognized as revenue within the 12 months following the balance sheet date are classified as current portion of deferred revenue. Amounts not expected to be recognized as revenue within the 12 months following the balance sheet date are classified as deferred revenue, net of current portion. Alliance Revenues The Company’s revenues have primarily been generated through collaborative research, development and/or commercialization agreements. The terms of these agreements may include payment to the Company of one or more of the following: nonrefundable, up-front license fees; research, development and commercial milestone payments; and other contingent payments due based on the activities of the counterparty or the reimbursement by licensees of costs associated with patent maintenance. Each of these types of revenue are recorded as Alliance revenues in the Company’s statements of operations. See Note 10, “Collaboration and License Agreements” for additional details regarding the Company’s collaboration and out-licensing arrangements. Note 2. Summary of Significant Accounting Policies (Continued) Research and Development Prepayments, Accruals and Related Expenses All research and development expenses are expensed as incurred. Research and development expenses are comprised of costs incurred in performing research and development activities, including drug development trials and studies, research collaborations, drug manufacturing, laboratory supplies, external research, payroll including stock-based compensation and overhead. The Company is required to estimate our accrued and prepared expenses for research and development activities performed by third parties, including Clinical Research Organizations (“CRO’s”) and clinical investigators. These estimates are made as of the reporting date of the work completed over the life of the individual study in accordance with agreements established with CRO’s and other clinical sites. Some CRO’s invoice the Company on a monthly basis, while others invoice upon the achievement of milestones. The Company determines the estimates of research and development activities incurred at the end of each reporting period through discussion with internal personnel, outside service providers, and research collaboration partners as to the progress or stage of completion of trials or services, as of the end of the reporting period, pursuant to contracts with clinical trial centers or CRO’s and the agreed upon fee to be paid for such services. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are deferred and capitalized. The capitalized amounts are expensed as the related goods are accepted by the Company or the services are performed. As of December 31, 2021 and 2020, the Company recorded approximately Stock-Based Compensation The Company accounts for stock-based compensation using ASC 718, Compensation – Stock Compensation Equity – Equity Based Payments to Non-Employees The Company recognizes all share-based payments to employees and directors as expense in the statements of operations based on their fair values. The Company records compensation expense on a straight-line basis over an award’s requisite service period, or vesting period, based on the award’s fair value at the date of grant. Vesting for time-based options and restricted stock units is generally four years for employees and one year for directors. The Company uses a Black-Scholes option-pricing model to determine the fair value of each option grant as of the date of grant for expense incurred. The Black-Scholes option pricing model requires inputs for risk-free interest rate, dividend yield, expected stock price volatility and expected term of the options. Forfeitures are accounted for as they occur. See Note 11, “Stock-based Compensation” for additional details. Income Taxes An asset and liability approach is used for financial accounting and reporting for income taxes. Deferred income taxes arise from temporary differences between income tax and financial reporting and principally relate to recognition of revenue and expenses in different periods for financial and tax accounting purposes and are measured using currently enacted tax rates and laws. In addition, a deferred tax asset can be generated by a net operating loss carryover. If it is more likely than not that some portion or all of a deferred tax asset will not be realized, a valuation allowance is recognized. In the event the Company is charged interest or penalties related to income tax matters, the Company would record such interest as interest expense and would record such penalties as other expense in the Statements of Operations. No such charges have been incurred by the Company. For each of the years ended December 31, 2021, 2020 and 2019, the Company had no uncertain tax positions. See Note 13, “Income Taxes” for additional details. Note 2. Summary of Significant Accounting Policies (Continued) Net Income (Loss) per Common Share applicable to Common Stockholders The Company uses the two-class method to compute net income per common share during periods the Company realizes net income and has securities outstanding (e.g. redeemable convertible preferred stock) that entitle the holder to participate in dividends and earnings of the Company. In addition, the Company analyzes the potential dilutive effect of outstanding redeemable convertible preferred stock under the "if-converted" method when calculating diluted earnings per share and reports the more dilutive of the approaches (two class or "if-converted"). The two-class method is not applicable during periods with a net loss, as the holders of the redeemable convertible preferred stock have no obligation to fund losses. The Company also analyzes the potential dilutive effect of outstanding stock options, unvested restricted stock units, warrants and shares underlying future tranche rights under the treasury stock method (as applicable), during periods of income, or during periods in which income is recognized related to changes in fair value of its liability-classified securities. New Accounting Pronouncements From time to time, new accounting pronouncements are issued by the FASB and rules are issued by the SEC that the Company has or will adopt as of a specified date. Unless otherwise noted, management does not believe that any other recently issued accounting pronouncements issued by the FASB or guidance issued by the SEC had, or is expected to have, a material impact on the Company’s present or future financial statements. Recently Adopted Accounting Pronouncements In June 2016, the FASB issued Accounting Standard Update (“ASU”) No. 2016-13, Financial Instruments Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments In August 2018, the FASB issued ASU No. 2018-13, Disclosure Framework Changes to the Disclosure Requirements for Fair Value Measurement Fair Value Measurement In August 2020, the FASB issued ASU No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06”), which simplifies the guidance on an issuer’s accounting for convertible instruments and contracts in its own equity. The Company adopted ASU 2020-06 in the first quarter of 2021. The adoption of this ASU did not have a material effect on the Company’s financial statements. COVID-19 While the Company is not aware of a material impact from the continuation of the coronavirus ("COVID-19") pandemic through December 31, 2021, the full extent to which the COVID-19 pandemic will directly or indirectly impact the Company’s business, results of operations, and financial condition, depends on future developments. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Measurements | |
Fair Value Measurements | Note 3. Fair Value Measurements Assets and Liabilities Measured at Fair Value on a Recurring Basis The Company applies the guidance in ASC 820, Fair Value Measurement The Company uses a fair value hierarchy, which distinguishes between assumptions based on market data (observable inputs) and an entity's own assumptions (unobservable inputs). The guidance requires that fair value measurements be classified and disclosed in one of the following three categories: ● Level 1: Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities; ● Level 2: Quoted prices in markets that are not active or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liability; and ● Level 3: Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e., supported by little or no market activity). Determining which category an asset or liability falls within the hierarchy requires significant judgment. The Company evaluates its hierarchy disclosures each reporting period. There were no transfers between Level 1 2, 3 year ended December 31 2021 The table below presents the assets and liabilities measured and recorded in the financial statements at fair value on a recurring basis at December 31, 2021 and 2020 categorized by the level of inputs used in the valuation of each asset and liability. December 31, 2021 (In thousands) Total Level 1 Level 2 Level 3 Assets Cash $ 250 $ 250 $ — $ — Cash equivalents – money market funds 32,295 32,295 — — Total assets $ 32,545 $ 32,545 $ — $ — December 31, 2020 (In thousands) Total Level 1 Level 2 Level 3 Assets Cash $ 250 $ 250 $ — $ — Cash equivalents – money market funds 32,979 32,979 — — Short-term investments – commercial paper 3,499 — 3,499 — Short-term investments – US treasury bills 1,000 — 1,000 — Total assets $ 37,728 $ 33,229 $ 4,499 $ — Liabilities Warrant liability $ 6,983 $ — $ — $ 6,983 Future tranche right liability 118,803 — — 118,803 Total liabilities $ 125,786 $ — $ — $ 125,786 The Level 1 assets consist of money market funds, which are actively traded daily. The Level 2 assets consist of commercial paper and US treasury bills whose fair value may not represent actual transactions of identical securities. The fair value of commercial paper is generally determined based on the relationship between the investment’s discount rate and the discount rates of the same issuer’s commercial paper available in the market which may not be actively traded daily. Since these fair values may not be based upon actual transactions of identical securities, they are classified as Level 2. Note 3. Fair Value Measurements (Continued) Changes in Level 3 Liabilities Measured at Fair Value on a Recurring Basis Warrant Liability and Future Tranche Right Liability The reconciliation of the Company's warrant and future tranche right liability measured at fair value on a recurring basis using unobservable inputs (Level 3) is as follows: Future Warrant Tranche Right (In thousands) Liability Liability Balance, December 31, 2019 $ 3,241 $ 46,436 Change in the fair value of liability 3,742 72,367 Balance, December 31, 2020 $ 6,983 $ 118,803 Change in the fair value of liability (1) (6,983) (118,803) Balance, December 31, 2021 $ — $ — (1) During the year ended December 31, 2021, the Company’s liability-classified warrants and future tranche rights terminated, and accordingly, the liabilities were derecognized. See Notes 7 and 8. Assumptions Used in Determining Fair Value of Liability-Classified Warrants The Company utilizes an option pricing model to value its liability-classified warrants. Inherent in the valuation model are assumptions related to volatility, risk-free interest rate, expected term, dividend rate, and other scenarios (i.e. probability of complex features of the warrants being triggered). The fair value of the warrants has been estimated with the following weighted-average assumptions: December 31, December 31, 2020 2019 Risk-free interest rate 0.50% 1.79% Expected dividend yield — — Expected term (years) 5.98 6.98 Expected volatility 80% 80% Exercise price (per share) $ 1.52 $ 1.52 Assumptions Used in Determining Fair Value of Future Tranche Rights Th e Company utilizes a lattice model to value the Series B2 and B3 future tranche rights and a Monte Carlo simulation to value the Series B4 future tranche rights. The Company selected these models as it believes they are reflective of all significant assumptions that market participants would likely consider in negotiating the transfer of the Future Tranche Rights (as defined in Note 7). Such assumptions include, among other inputs, stock price volatility, risk-free rates, and expected terms inclusive of early exercise and cancellation assumptions . The estimated fair value of the Future Tranche Rights is determined using Level 2 and Level 3 inputs. Significant inputs and assumptions used in the valuation models are as follows: December 31, December 31, 2020 2019 Risk-free interest rate 0.64% - 0.73% 1.84% - 1.88% Expected dividend yield — — Expected term (years) of call options on preferred stock 0.25 - 1.12 1.16 - 2.16 Expected term (years) of warrants 7.25 - 8.12 8.16 - 9.16 Expected volatility 80% 80% Exercise price (per share) for common stock equivalent for preferred stock and warrant $ 1.52 - 1.82 $ 1.52 - 1.82 |
Investments
Investments | 12 Months Ended |
Dec. 31, 2021 | |
Investments | |
Investments | Note 4. Investments The Company had no available-for-sale investments at December 31, 2021. The Company’s available-for-sale investments at fair value consisted of the following at December 31, 2020: December 31, 2020 Gross Gross Estimated Unrealized Unrealized Fair (In thousands) Cost (Losses) Gains Value Short-term investments – commercial paper $ 3,499 $ — $ — $ 3,499 Short-term investments – US treasury bills 1,000 — — 1,000 Total short-term investments $ 4,499 $ — $ — $ 4,499 The Company had no realized gains or losses from the sale of investments in available-for-sale securities during each of the years ended December 31, 2021 and 2020. In accordance with ASU 2016-13, if the fair value of the Company’s investments in available-for-sale debt securities is less than the amortized cost, the Company records (i) an allowance for credit losses with a corresponding charge to net income (loss) for any credit-related impairment, with subsequent improvements in expected credit losses recognized as a reversal of the allowance, and/or (ii) any non-credit impairment loss to other comprehensive income (loss). As of December 31, 2020, the Company had no allowance for credit losses pertaining to the Company’s investments in available-for-sale debt securities. Additionally, there were no impairment charges or recoveries recorded during each of the years ended December 31, 2021 and 2020. |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2021 | |
Property and Equipment | |
Property and Equipment | Note 5. Property and Equipment At December 31, 2021 and 2020, net property and equipment at cost consisted of the following: December 31, December 31, (In thousands) 2021 2020 Leasehold improvements $ 107 $ 107 Equipment and other 712 770 Total property and equipment, at cost $ 819 $ 877 Less: Accumulated depreciation and amortization 797 833 Property and equipment, net $ 22 $ 44 Depreciation and amortization expense on property and equipment was approximately $0.1 million for each of the years ended December 31, 2021, 2020, and 2019. |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2021 | |
Accrued Expenses | |
Accrued Expenses | Note 6. Accrued Expenses At December 31, 2021 and 2020, accrued expenses consisted of the following: December 31, December 31, (In thousands) 2021 2020 Payroll and related costs $ 477 $ 2,133 Clinical and nonclinical trial expenses 2,909 3,229 Professional and consulting fees 591 584 Other 111 126 Total accrued expenses $ 4,088 $ 6,072 |
Redeemable Convertible Preferre
Redeemable Convertible Preferred Stock | 12 Months Ended |
Dec. 31, 2021 | |
Redeemable Convertible Preferred Stock | |
Redeemable Convertible Preferred Stock | Note 7. Redeemable Convertible Preferred Stock December 2019 Private Placement On December 23, 2019, the Company entered into the December 2019 Securities Purchase Agreement, under which the Company sold 23,684 shares of Series B1 convertible preferred stock (“Series B1 Preferred Stock”) and warrants to purchase 2,368,400 shares of the Company’s common stock at an exercise price of $1.52 per share (or, if the holder elected to exercise the warrants for shares of Series B1 Preferred Stock, 23,684 shares of Series B1 Preferred Stock at an exercise price of $152 per share) for aggregate gross proceeds of $3.9 million (the “Initial Closing”). In addition, the Company agreed to sell to the purchasers, at their option and subject to certain conditions, (i) 98,685 shares of Series B2 convertible preferred stock (“Series B2 Preferred Stock”) and 9,868,500 warrants to purchase common stock at an exercise price of $1.52 per share (or, at the election of the holder, 98,685 shares of Series B2 Preferred Stock at an price of $152 per share), for aggregate gross proceeds of $15 million (the “Series B2 Tranche”), (ii) 82,418 shares of Series B3 convertible preferred stock (“Series B3 Preferred Stock”) and 6,593,440 warrants to purchase common stock at an exercise price of $1.82 per share (or, at the election of the holder, 65,934 shares of Series B3 Preferred Stock at a price of $182 per share), for aggregate gross proceeds of $15 million (the “Series B3 Tranche”), and (iii) 82,418 shares of Series B4 convertible preferred stock (“Series B4 Preferred Stock”) and 6,593,440 warrants to purchase common stock at an exercise price of $1.82 per share (or, at the election of the holder, 65,934 shares of Series B3 Preferred Stock at a price of $182 per share), for aggregate gross proceeds of $15 million (the “Series B4 Tranche”) over a period of up to 21 months following the Company’s 2020 Annual Meeting of Stockholders held on May 12, 2020, where stockholders of the Company voted to approve an amendment to the Company’s Restated Certificate of Incorporation to increase the authorized number of shares of the Company’s common stock to 140,000,000. As consideration for the future tranche rights, the Company received aggregate gross proceeds of $6.2 million in December 2019. The purchase and sale of the securities issuable under the Series B2, B3, and B4 tranches described above were subject to three separate closings, each to be conducted at the purchasers’ discretion. The right of the purchasers to purchase Series B2, Series B3 and Series B4 Preferred Stock was set to expire on the 10th business day following the Company’s ORR Data Announcement as defined in the for its ILLUMINATE-301 study. Accounting Considerations The Company determined that the Series B1 Preferred Stock, the accompanying Series B1 warrants, and each of the future tranche rights represent freestanding financial instruments. The Series B1 warrants and the future tranche rights were classified as liabilities until their termination in March 2021 as the underlying shares were potentially redeemable and such redemption was deemed to be outside of the Company’s control. The $10.1 million in gross proceeds received in December 2019 was allocated to the Series B1 warrants and the Future Tranche Rights based on their estimated fair values of $2.6 million and $35.5 million, respectively. The excess fair value of $28.0 million over the gross proceeds received of $10.1 million was recorded as a deemed dividend to Baker Brothers, an existing significant shareholder. Costs incurred in connection with the December 2019 Securities Purchase Agreement were expensed as incurred. Due to the redeemable nature of the Series B1 Preferred Stock, the Series B1 Preferred Stock was classified as temporary equity and the carrying value was being accreted to its redemption value as of December 31, 2020 and while the Series B1 Preferred Stock was outstanding during 2021. During 2021, all the Company’s 23,684 shares of Series B1 Preferred Stock outstanding were converted into shares of the Company’s common stock. See Note 15 for details. For the years ended December 31, 2021 and 2020, accretion was de minimis. |
Stockholders' Equity (Deficit)
Stockholders' Equity (Deficit) | 12 Months Ended |
Dec. 31, 2021 | |
Stockholders' Equity (Deficit) | |
Stockholders' Equity (Deficit) | Note 8. Stockholders’ Equity (Deficit) Preferred Stock The Restated Certificate of Incorporation, as amended, of the Company permits its Board of Directors to issue up to 5,000,000 shares of preferred stock, par value $0.01 per share, in one or more series, to designate the number of shares constituting such series, and fix by resolution, the powers, privileges, preferences and relative, optional or special rights thereof, including liquidation preferences and dividends, and conversion and redemption rights of each such series. As of December 31, 2020, the Company has designated the following class of preferred stock: ● Series A: 1,500,000 authorized shares of Series A Convertible Preferred Stock ● Series B1: 277,921 authorized shares of Series B1 Redeemable Convertible Preferred Stock ● Series B2: 98,685 authorized shares of Series B2 Redeemable Convertible Preferred Stock ● Series B3: 82,814 authorized shares of Series B3 Redeemable Convertible Preferred Stock ● Series B4: 82,814 authorized shares of Series B4 Redeemable Convertible Preferred Stock Series A Convertible Preferred Stock . Series B Convertible Preferred Stock. Common Stock Common Stock Authorized As of December 31, 2021, the Company had 140,000,000 shares of common stock authorized of which 23,918,172 shares of common stock were reserved for issuance upon the exercise of outstanding warrants and options to purchase common stock, outstanding restricted stock units, the conversion of Series A convertible preferred stock, shares required to be reserved under the LPC Purchase Agreement (defined below), and shares available for grant under the Company’s 2013 Stock Incentive Plan and shares available for purchase under the Company’s 2017 Employee Stock Purchase Plan. The expiration of the LPC Purchase Agreement on March 4, 2022 decreased the reserved shares of the common stock to 14,906,278 shares. Note 8. Stockholders’ Equity (Deficit) (Continued) Put Shares Pursuant to the terms of a unit purchase agreement dated as of May 5, 1998, the Company issued and sold a total of 149,960 shares of common stock (the “Put Shares”) at a price of $128.00 per share. Under the terms of the unit purchase agreement, the initial purchasers (the “Put Holders”) of the Put Shares have the right (the “Put Right”) to require the Company to repurchase the Put Shares. The Put Right may not be exercised by any Put Holder unless: (1) the Company liquidates, dissolves or winds up its affairs pursuant to applicable bankruptcy law, whether voluntarily or involuntarily; (2) all of the Company’s indebtedness and obligations, including without limitation the indebtedness under the Company’s then outstanding notes, has been paid in full; and (3) all rights of the holders of any series or class of capital stock ranking prior and senior to the common stock with respect to liquidation, including without limitation the Series A convertible preferred stock, have been satisfied in full. The Company may terminate the Put Right upon written notice to the Put Holders if the closing sales price of its common stock exceeds $256.00 per share for the twenty As of December 31, 2021, the Company has repurchased or received documentation of the transfer of 49,993 Put Shares and 4,472 of the Put Shares continued to be held in the name of Put Holders. The Company cannot determine at this time what portion of the Put Rights of the remaining 95,494 Put Shares have terminated. Equity Financings April 2020 Private Placement On April 7, 2020, the Company entered into a Securities Purchase Agreement with Pillar Partners Foundation, L.P. (“Pillar Partners”), a related party as more fully described in Note 15, which was amended on December 11, 2020 (as amended to date, the “April 2020 Securities Purchase Agreement”), under which the Company sold 3,039,514 shares of common stock and accompanying warrants to purchase 3,039,514 shares of the Company’s common stock with an exercise price of $2.28 per share, for aggregate gross proceeds of $5.0 million. Each share and the accompanying common warrant had a combined purchase price of $1.645, which included $0.125 for each share of common stock underlying each warrant. The April 2020 Securities Purchase Agreement also provided for the option for Pillar Partners to purchase 2,747,252 shares of the Company’s common stock (or pre-funded warrants to purchase shares of the Company’s common stock at an exercise price of $0.01 in lieu of certain shares to the extent that purchasing such shares will cause Pillar Investment Entities (as defined below) to beneficially own in excess of 19.99% of the total number of shares of common stock outstanding post transaction) and warrants to purchase up to 1,373,626 shares of the Company’s common stock (with an exercise price of $2.71), for aggregate gross proceeds of $5.0 million (the “April 2020 Private Placement Second Closing”). Subsequently, in December 2020, the April 2020 Private Placement Second Closing was consummated. Total net proceeds received pursuant to the April 2020 Securities Purchase Agreement, after deduction of offering expenses, was $9.8 million. Note 8. Stockholders’ Equity (Deficit) (Continued) July 2020 Private Placement On July 13, 2020, the Company entered into a Securities Purchase Agreement (the “July 2020 Securities Purchase Agreement”) with Pillar Partners, Pillar Pharmaceuticals 6 L.P. (“Pillar 6”), and Pillar Pharmaceuticals 7 L.P. (“Pillar 7” and, together with Pillar Partners and Pillar 6, the “July 2020 Purchasers”), each a related party as more fully described in Note 15, pursuant to which, among other things, provided the July 2020 Purchasers the option to purchase, at their sole discretion, pre-funded warrants to purchase up to 784,615 shares of the Company’s common stock, at an exercise price of $0.01 per share, and warrants to purchase up to 274,615 shares of the Company’s common stock, at an exercise price of $9.75, for aggregate gross proceeds of $5.1 million (the “July 2020 Private Placement Second Closing”). During the three months ended March 31, 2021, the option to purchase securities in the July 2020 Private Placement Second Closing terminated. As a result, the Company is no longer eligible to receive additional proceeds from the sale of additional securities pursuant to the July 2020 Securities Purchase Agreement. However, the July 2020 Purchasers still hold outstanding warrants previously issued under the July 2020 Securities Purchase Agreement, as detailed below under the heading “Common Stock Warrants”. Common Stock Purchase Agreement On March 4, 2019, the Company entered into a Purchase Agreement with Lincoln Park Capital Fund, LLC (“Lincoln Park”), which was amended on September 2, 2020 (as amended to date, the “LPC Purchase Agreement”), pursuant to which, upon the terms and subject to the conditions and limitations set forth therein, Lincoln Park has committed to purchase an aggregate of $35.0 million of shares of Company common stock from time to time at the Company’s sole discretion over a 36-month During the years ended December 31, 2021 and 2020, the Company sold 800,000 and 750,000 shares, respectively, pursuant to the LPC Purchase Agreement, resulting in net proceeds of $4.2 million and $1.7 million, respectively. The 36-month period noted above for expired on March 4, 2022; accordingly, the Company no longer has access to additional capital under the LPC Purchase Agreement subsequent to this date. "At-The-Market" Equity Program In November 2018, the Company entered into an Equity Distribution Agreement (the “ATM Agreement”) with JMP Securities LLC (“JMP”) pursuant to which the Company may issue and sell shares of its common stock having an aggregate offering price of up to $50.0 million (the “Shares”) through JMP as its agent. Subject to the terms and conditions of the ATM Agreement, JMP will use its commercially reasonable efforts to sell the Shares from time to time, based upon the Company’s instructions, by methods deemed to be an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended, or if specified by the Company, by any other method permitted by law, including but not limited to in negotiated transactions. The Company has no obligation to sell any of the Shares, and the Company or JMP may at any time suspend sales under the ATM Agreement or terminate the ATM Agreement. JMP is entitled to a fixed commission of 3.0% of the gross proceeds from Shares sold. During the years ended December 31, 2021 and 2020, the Company sold 5,117,357 and 3,608,713 Shares, respectively, pursuant to the ATM Agreement resulting in net proceeds, after deduction of commissions and other offering expenses, of $15.3 million and $12.3 million, respectively. As of March 31, 2022, the Company may sell up to an additional $19.5 million of shares under the ATM Agreement. Note 8. Stockholders’ Equity (Deficit) (Continued) Common Stock Warrants In connection with various financing transactions, the Company has issued warrants to purchase shares of the Company’s common stock and preferred stock. The Company accounts for common stock and preferred stock warrants as equity instruments or liabilities, depending on the specific terms of the warrant agreement. See Note 2 for further details on accounting policies related to the Company’s warrants. The following table summarizes outstanding warrants to purchase shares of the Company’s common stock and/or preferred stock as of December 31, 2021 and 2020: Number of Shares December 31, December 31, Weighted-Average Description 2021 2020 Exercise Price Expiration Date Liability-classified Warrants December 2019 Series B1 warrants (1) — 2,368,400 $ 1.52 Dec 2026 — 2,368,400 Equity-classified Warrants May 2013 warrants 15,437 1,949,754 $ 0.08 None September 2013 warrants 4,096 514,756 $ 0.08 None February 2014 warrants 2,171 266,006 $ 0.08 None April 2020 Private Placement first closing warrants 3,039,514 3,039,514 $ 2.28 Apr 2023 April 2020 Private Placement second closing warrants 1,373,626 1,373,626 $ 2.71 Dec 2023 April 2020 Private Placement second closing warrants 1,143,428 2,677,311 $ 0.01 None July 2020 Private Placement first closing warrants 389,731 2,014,234 $ 0.01 None July 2020 Private Placement first closing warrants 2,764,227 2,764,227 $ 2.58 Jul 2023 8,732,230 14,599,428 Total outstanding 8,732,230 16,967,828 (1) The Series B1 warrants were exercisable for either common stock (exercise price of $1.52 ) or Series B1 Convertible Preferred Stock (exercise price of $152 ) at the discretion of the warrant holder. However, as more fully disclosed in Note 7, the December 2019 Series B1 warrants were terminated during the three months ended March 31, 2021 contemporaneously with the termination of the future tranche rights. The table below is a summary of the Company's warrant activity for the year ended December 31, 2021. Number of Weighted-Average Warrants Exercise Price Outstanding at December 31, 2020 16,967,828 $ 1.28 Issued — — Exercised (1) (5,867,198) 0.04 Expired (2,368,400) 1.52 Outstanding at December 31, 2021 8,732,230 $ 2.04 (1) During th e year ended December 31, 2021, certain related parties were issued warrants as more fully described in Note 15. |
Alliance Revenue
Alliance Revenue | 12 Months Ended |
Dec. 31, 2021 | |
Alliance Revenue | |
Alliance Revenue | Note 9. Alliance Revenue There were no Alliance revenues for the years ended December 31, 2021 and 2020. Alliance revenue for the years ended December 31, 2019 represents revenue from contracts with customers accounted for in accordance with ASC 606. For the year ended December 31, 2019, the Company recognized Alliance revenues totaling $1.4 million which consistent primarily of revenues recognized under the Licensee Agreement, primarily related to the transfer of the IMO-8400 License and IMO-8400 drug product. See Note 10 for additional details regarding the Company’s collaboration arrangements. |
Collaboration and License Agree
Collaboration and License Agreements | 12 Months Ended |
Dec. 31, 2021 | |
Collaboration and License Agreements | |
Collaboration and License Agreements | Note 10. Collaboration and License Agreements Option and License Agreement with Licensee In April 2019, the Company entered into an amended and restated option and license agreement with a privately-held biopharmaceutical company (“Licensee”), pursuant to which the Company granted Licensee (i) exclusive worldwide rights to develop and market IMO-8400 for the treatment, palliation and diagnosis of all diseases, conditions or indications in humans (the “IMO-8400 License”), (ii) an exclusive right and license to develop IMO-9200 in accordance with certain IMO-9200 pre-option exercise protocols (the “IMO-9200 Option Period License”), and (iii) an exclusive one-year option, exercisable at Licensee’s discretion, to obtain the exclusive worldwide rights to develop and market IMO-9200 for the treatment, palliation and diagnosis of all diseases, conditions or indications in humans (the “IMO-9200 Option”) (collectively, the “Licensee Agreement”). In connection with the Licensee Agreement, the Company transferred certain drug material to Licensee for Licensee’s use in development activities. Licensee is solely responsible for the development and commercialization of IMO-8400 and, if Licensee exercises the IMO-9200 Option, Licensee would be solely responsible for the development and commercialization of IMO-9200. Under the terms of the Licensee Agreement, the Company received upfront, non-refundable fees totaling approximately $1.4 million and ownership of 10% of Licensee’s outstanding common stock, subject to future adjustment, for granting Licensee the IMO-8400 License, the IMO-9200 Option Period License and transfer of related drug materials. In addition, following expiry of the IMO-9200 Option in 2020, the Company is now only eligible to receive certain development and sales-based milestone payments and royalties on global net sales related to the IMO-8400 Compound and potential future IMO-8400 Products, each as defined in the Licensee Agreement. The Company does not anticipate the receipt of any of the future milestones or royalties in the short term, if ever. The Company accounts for the Licensee Agreement in accordance with ASC 606. As of December 31, 2021, the total transaction price of the contract was $1.4 million, which excluded the Option Fee and all development and sales milestones as all such payments were fully constrained. Additionally, as of December 31, 2021, there were no remaining performance obligations under the Licensee Agreement. The Company re-evaluates its performance obligations and transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur. As disclosed above, in connection with the Licensee Agreement, the Company owns 10% of Licensee’s outstanding common stock, subject to future adjustment. The Company evaluated the guidance in ASC 321, Investments-Equity Securities Note 10. Collaboration and License Agreement (Continued) Collaboration Agreement with Scriptr In February 2021, the Company entered into a collaboration and option agreement with Scriptr, pursuant to which (i) Scriptr and Idera will conduct a research collaboration utilizing Scriptr Platform Technology (“SPT”) to identify, research and develop gene therapy candidates (each, a “Collaboration Candidate”) for the treatment, palliation, diagnosis or prevention of (a) myotonic dystrophy type 1 (“DM1 Field”) and (b) Friedreich’s Ataxia (“FA Field”) on a Research Program-by-Research Program basis, as applicable, and (ii) the Company was granted an exclusive option, in its sole discretion, to make effective the Scriptr License Agreement, as defined below, for a given Research Program, as defined below, to make use of Collaboration Candidates and related intellectual property (collectively, the “Scriptr Agreement”). Pursuant to the Scriptr Agreement, Scriptr will use commercially reasonable efforts to carry out research activities set forth in accordance with the applicable DM1 Field and FA Field research plans, including certain pre-clinical proof of concept studies, to identify research Collaboration Candidates utilizing SPT (each, a “Research Program”). Following the completion of activities under a given Research Program, Scriptr will prepare and submit to us a comprehensive data package (each, a “Data Package”) that summarizes, on a Research Program-by-Research Program basis, any Collaboration Candidates researched under the Research Program, including any data and results. Upon receipt of a Data Package, Idera has, in its sole discretion, up to two-hundred seventy ( 270 In partial consideration of the rights granted by Scriptr to Idera under the Scriptr Agreement, the Company made a one-time, non-creditable and non-refundable payment to Scriptr during the first quarter of 2021. In order to fund the Research Programs, Idera will reimburse Scriptr for costs incurred by or on behalf of Scriptr in connection with the conduct of each Research Program during the research term in accordance with the applicable Research Program budget and payment schedule. The Company incurred approximately $2.1 million in research and development expenses under the Scriptr Agreement during the year ended December 31, 2021. |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2021 | |
Stock-Based Compensation | |
Stock-Based Compensation | Note 11. Stock-based Compensation As of December 31, 2021, the only equity compensation plans from which the Company may currently issue new awards are the Company’s 2013 Stock Incentive Plan (as amended to date, the “2013 Plan”) and 2017 Employee Stock Purchase Plan (the “2017 ESPP”), each as more fully described below. Equity Incentive and Employee Stock Purchase Plans 2013 Stock Incentive Plan The Company's board of directors adopted the 2013 Plan, which was approved by the Company’s stockholders effective July 26, 2013. Amendments to the 2013 Plan were approved by the Company’s stockholders in June 2014, June 2015, June 2017 and June 2019. The 2013 Plan is intended to further align the interests of the Company and its stockholders with its employees, including its officers, non-employee directors, consultants and advisers by providing equity-based incentives. The 2013 Plan allows for the issuance of incentive stock options intended to qualify under Section 422 of the Internal Revenue Code, non-statutory stock options, stock appreciation rights, restricted stock awards, restricted stock units (“RSUs”), other stock-based awards and performance awards. The total number of shares of common stock authorized for issuance under the 2013 Plan is 5,653,057 shares of the Company’s common stock, plus such additional number of shares of common stock (up to 868,372 shares) as is equal to the number of shares of common stock subject to awards granted under the Company’s 2005 Stock Incentive Plan or 2008 Stock Incentive Plan (the “2008 Plan”), to the extent such awards expire, terminate or are otherwise surrendered, canceled, forfeited or repurchased by the Company at their original issuance price pursuant to a contractual repurchase right. As of December 31, 2021, options to purchase a total of 4,721,038 shares of common stock and 575,703 RSUs were outstanding and up to 199,873 shares of common stock remained available for grant under the 2013 Plan. Other Awards and Inducement Grants The Company has not made any awards pursuant to other equity incentive plans, including the 2008 Plan, since the Company’s stockholders approved the 2013 Plan. As of December 31, 2021, options to purchase a total of 155,968 shares of common stock were outstanding under the 2008 Plan. In addition, as of December 31, 2021, non-statutory stock options to purchase an aggregate of 325,000 shares of common stock were outstanding that were issued outside of the 2013 Plan to certain employees in 2017, 2015 and 2014 pursuant to the Nasdaq inducement grant exception as a material component of new hires’ employment compensation. 2017 Employee Stock Purchase Plan The Company’s board of directors adopted the 2017 ESPP which was approved by the Company’s stockholders and became effective June 7, 2017. An amendment to the 2017 ESPP was approved by the Company’s stockholders in June 2019. The 2017 ESPP is intended to qualify as an "employee stock purchase plan" as defined in Section 423 of the Internal Revenue Code, and is intended to encourage our employees to become stockholders of ours, to stimulate increased interest in our affairs and success, to afford employees the opportunity to share in our earnings and growth and to promote systematic savings by them. The total number of shares of common stock authorized for issuance under the 2017 ESPP is 412,500 shares of common stock, subject to adjustment as described in the 2017 ESPP. Note 11. Stock-based Compensation (Continued) Stock Purchase Plan Administration The 2017 ESPP provides for offerings to employees to purchase common stock with offerings beginning on dates determined by the compensation committee of the board of directors or on the first business day thereafter. Each offering begins a “plan period” during which payroll deductions are to be made and held for the purchase of common stock at the end of the plan period. The compensation committee may, at its discretion, choose a plan period of or less for subsequent offerings and/or choose a different commencement date for offerings. During each plan period participating employees may elect to have a portion of their compensation, ranging from For the years ended December 31, 2021, 2020 and 2019, the Company issued 49,117, 75,999, and 60,953, shares of common stock, in each year respectively, under the 2017 ESPP and received proceeds of $0.1 million for each year, as a result of stock purchases. Accounting for Stock-based Compensation The Company recognizes non-cash compensation expense for stock-based awards under the Company’s equity incentive plans and employee stock purchases under the Company’s 2017 ESPP as follows: ● Stock Options: Compensation cost is recognized over an award’s requisite service period, or vesting period, using the straight-line attribution method, based on the grant date fair value determined using the Black-Scholes option-pricing model. ● RSUs: Compensation cost for time-based RSUs, which vest over time based only on continued service, is recognized on a straight-line basis over the requisite service period based on the fair value of the Company’s common stock on the date of grant. Compensation cost for awards that are subject to market considerations is recognized on a straight-line basis over the implied requisite service period, based on the grant date fair value estimated using a Monte Carlo simulation. Compensation cost for awards that are subject to performance conditions is recognized over the period of time commencing when the performance condition is deemed probable of achievement based on the fair value of the Company’s common stock on the date of grant. ● Employee Stock Purchases: Compensation cost is recognized over each plan period based on the fair value of the look-back provision, calculated using the Black-Scholes option-pricing model, considering the 15% discount on shares purchased. Total stock-based compensation expense attributable to stock-based payments made to employees and directors and employee stock purchases included in operating expenses in the Company's statements of operations for the years ended December 31, 2021, 2020 and 2019 was as follows: (in thousands) 2021 2020 2019 Stock-based compensation: Research and development Employee Stock Purchase Plan $ 28 $ 88 $ 36 Equity Incentive Plan 546 673 1,312 $ 574 $ 761 $ 1,348 General and administrative Employee Stock Purchase Plan $ 3 $ 9 $ 20 Equity Incentive Plan 1,960 2,871 2,477 $ 1,963 $ 2,880 $ 2,497 Total stock-based compensation expense $ 2,537 $ 3,641 $ 3,845 Note 11. Stock-based Compensation (Continued) During the years ended December 31, 2021, 2020 and 2019, the weighted average fair market value of stock options granted was $1.54, $1.25, and $1.64, respectively. Assumptions Used in Determining Fair Value of Stock Options Inherent in the Black-Scholes option-pricing model are the following assumptions: Volatility Risk-free interest rate Expected term Dividend rate. Forfeitures The fair value of each option award at the date of grant was estimated using the Black-Scholes option pricing model. All options granted during the three years in the period ended December 31, 2021 were granted at exercise prices equal to the fair market value of the common stock on the dates of grant . The following weighted average assumptions apply to the options to purchase 1,356,700, 1,215,382, and 1,279,016 shares of common stock granted to employees and directors during the years ended December 31, 2021, 2020 and 2019, respectively: 2021 2020 2019 Average risk-free interest rate 0.4% 1.0% 2.1% Expected dividend yield — — — Expected lives (years) 3.6 3.9 3.7 Expected volatility 94% 84% 84% Weighted average exercise price (per share) $ 2.68 $ 2.08 $ 2.75 All options granted during the years ended December 31, 2021, 2020 and 2019 were granted at exercise prices equal to the fair market value of the common stock on the dates of grant . Stock Option Activity The following table summarizes stock option activity for the year ended December 31, 2021. ($ in thousands, except per share data) Stock Options Weighted-Average Exercise Price Weighted-Average Remaining Contractual Life (in years) Aggregate Intrinsic Value Outstanding at December 31, 2020 4,614,323 $ 9.78 6.8 $ 2,949 Granted 1,356,700 2.68 Exercised (22,500) 2.11 Forfeited (261,426) 4.44 Expired (485,091) 11.52 Outstanding at December 31, 2021 (1) 5,202,006 $ 8.06 5.9 $ — Exercisable at December 31, 2021 4,096,875 $ 9.62 5.1 $ — (1) Includes both vested stock options as well as unvested stock options for which the requisite service period has not been rendered but that are expected to vest based on achievement of a service condition. Note 11. Stock-based Compensation (Continued) In March 2021, the Company accelerated the vesting of 1,535,578 options, which were previously granted from 2019 to 2021. The modification results in an incremental stock based compensation charge that was not significant. As of December 31, 2021, there was $1.2 million of unrecognized compensation cost related to unvested options, which the Company expects to recognize over a weighted average period of 2.1 years. Restricted Stock Activity The following table summarizes restricted stock activity for the year ended December 31, 2021: Time-based Awards Market/Performance-based Awards ($ in thousands, except per share data) Number of Shares Weighted-Average Grant Date Fair Value Number of Shares Weighted-Average Grant Date Fair Value Nonvested shares at December 31, 2020 354,003 $ 2.27 549,318 $ 1.54 Granted Cancelled (48,563) 2.31 (42,290) 1.54 Vested (236,765) 2.25 — — Nonvested shares at December 31, 2021 68,675 $ 2.30 507,028 $ 1.54 Time-based Restricted Stock Units In December 2020, the Company’s Chief Executive Officer was granted an award of 128,170 RSUs, pursuant to the 2013 Plan, in lieu of salary pursuant to a January 10, 2020 amendment to the officers’ employment agreement. The RSUs were fully vested on the grant date. In March 2021, the Company accelerated the vesting of 137,872 unvested time-based restricted stock units which were previously granted in 2019 and 2020. The modification results in an incremental stock based compensation charge that was not significant. During the year ended December 31, 2021, the Company recognized $0.3 million of compensation expense related to these awards. As of December 31, 2021, there was Market/Performance-based Restricted Stock Units In July 2020, the Company granted RSUs to certain employees, including executive officers, under the 2013 Plan, with vesting that may occur upon a combination of specific performance and/or market conditions. Accordingly, the Company views these RSUs as two separate awards: (i) an award that vests if the market condition is achieved, and (ii) an award that vests whether or not the market condition is achieved, so long as the performance condition is achieved. The Company is currently recognizing compensation expense for these awards over the estimated requisite service period of 2.36 years based on the estimated fair value when considering the market condition of the award, which was determined using a Monte Carlo simulation. During the year ended December 31, 2021, the Company recognized $0.3 million of compensation expense related to these awards. As of December 31, 2021, the remaining unrecognized compensation cost for the market-based component of these awards, which is expected to be recognized over a weighted-average period of 0.9 years, is $0.3 million. In addition, should the performance condition be achieved, the Company would recognize an additional $0.3 million of compensation expense. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies | |
Commitments and Contingencies | Note 12. Commitments and Contingencies Lease Commitments As of December 31, 2021, the Company’s leased assets primarily consisted of its office headquarters in Exton, Pennsylvania. During 2021, 2020 and 2019, rent expense, including real estate taxes, was $0.3 million, $0.4 million, and $0.3 million, respectively. The leases are classified as operating leases. Future minimum commitments as of December 31, 2021 under the Company’s lease agreements are approximately: December 31, Operating Leases (in thousands) 2022 249 2023 250 2024 240 2025 101 $ 840 The Company entered into the Exton, Pennsylvania facility lease on April 1, 2015, which was subsequently amended on September 23, 2015 to include additional space. The Company currently leases approximately 11,000 square feet of office space at our Exton facility. The lease expires on May 31, 2025. Vendor Financing Arrangement In October 2020, the Company entered into a short-term financing arrangement with a third-party vendor to finance insurance premiums. As of December 31, 2020, the balance of $0.4 million, was paid in monthly installments through June 2021. Accordingly, as of December 31, 2021, no amounts were outstanding under this agreement. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2021 | |
Income Taxes | |
Income Taxes | Note 13. Income Taxes As of December 31, 2021, the Company had cumulative federal and state net operating loss carryforwards (“NOLs”) of approximately $327.5 million and $322.0 million available to reduce federal and state taxable income, respectively. As a result of the Tax Cuts and Jobs Act of 2017, federal net operating losses incurred for taxable years beginning after January 1, 2018 have an unlimited carryforward period, but can only be utilized to offset 80% of taxable income in future taxable periods. Of the $327.5 million of federal NOLs, $130.1 million have an unlimited carryforward and the remaining NOLs are still subject to expiration through 2037. State NOLs are still subject to expiration according to the laws of each respective jurisdiction. The Company files state tax returns in Massachusetts and Pennsylvania Sections 382 and 383 of the Internal Revenue Code prescribe limitations on the amount of NOLs and tax credit carryforwards that may be utilized in any one year. The Company has completed several financings since the effective date of the Tax Reform Act of 1986, which as of December 31, 2021, have resulted in ownership changes that will significantly limit the Company’s ability to utilize its net operating loss and tax credit carryforwards. In December 2017, the Company completed a study which determined that ownership changes had occurred. The federal and state net operating loss and tax credit carryforwards and related deferred tax assets shown in the table below have been adjusted to reflect the limitations that resulted from this study. As no study has been completed subsequent to 2017, additional ownership change limitations may result from ownership changes that have occurred, or may occur in the future. The Company continues to monitor equity activity and potential ownership changes. Note 13. Income Taxes (Continued) As of December 31, 2021 and 2020, the components of the deferred tax assets are approximately as follows: (in thousands) 2021 2020 Operating loss carryforwards $ 90,550 $ 90,895 Tax credit carryforwards 28,226 26,550 Stock-based compensation 6,902 6,820 Capitalized research and development 7,818 — Lease liabilities 220 276 Other 70 162 Total deferred tax assets 133,786 124,703 Right-of-use asset (213) (270) Valuation allowance (133,573) (124,433) Net deferred tax assets $ — $ — The Company has provided a full valuation allowance for its deferred tax asset due to the uncertainty surrounding the ability to realize these assets. The difference between the U.S. federal corporate tax rate and the Company’s effective tax rate for the years ended December 31, 2021, 2020 and 2019 is as follows: 2021 2020 2019 Expected federal income tax rate (21.0) % (21.0) % (21.0) % Expiring credits and NOLs — — — Change in valuation allowance (9.3) 10.6 26.2 Federal and state credits 1.7 (3.1) (8.1) State income taxes, net of federal benefit 2.1 (1.9) (4.7) Warrant and future tranche right revaluation loss 26.9 14.2 4.3 Stock-based compensation — 0.2 0.5 Other (0.4) 1.0 2.8 Effective tax rate 0.0 % 0.0 % 0.0 % The Company applies ASC 740-10, Accounting for Uncertainty in Income Taxes, an interpretation of ASC 740 The Company has not conducted a study of its research and development tax credit carryforwards. Such a study might result in an adjustment to the Company’s research and development credit carryforwards, however, until a study is completed and any adjustment is known, no amounts are being presented as an uncertain tax position under ASC 740-10. A full valuation allowance has been provided against the Company’s research and development credits and, if an adjustment is required, this adjustment would be offset by an adjustment to the valuation allowance. Thus, there would be no impact on the statements of operations if an adjustment was required. The Company files income tax returns in the U.S. federal, Massachusetts and Pennsylvania jurisdictions. The Company is no longer subject to tax examinations for years before 2018, except to the extent that it utilizes tax attributes that originated before 2018. The Company does not believe there will be any material changes in its unrecognized tax positions over the next 12 months. The Company has not incurred any interest or penalties. In the event that the Company is assessed interest or penalties at some point in the future, they will be classified in the statements of operations as general and administrative expense. |
Employee Benefit Plan
Employee Benefit Plan | 12 Months Ended |
Dec. 31, 2021 | |
Employee Benefit Plan | |
Employee Benefit Plan | Note 14. Employee Benefit Plan The Company has an employee benefit plan under Section 401(k) of the Internal Revenue Code. The plan allows employees to make contributions up to a specified percentage of their compensation. Under the plan, the Company matches up to 5% of employee base salary, by matching 100% of the first 5% of annual base salary contributed by each employee. Approximately |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2021 | |
Related Party Transactions | |
Related Party Transactions | Note 15. Related Party Transactions Baker Brothers Julian C. Baker, a member of the Company’s Board of Directors until his resignation in September 2018, is a principal of Baker Bros. Advisors, LP. Additionally, Kelvin M. Neu, a member of Company’s Board until his resignation in June 2019, is an employee of Baker Bros. Advisors, LP. As of December 31, 2021, Baker Bros. Advisors, LP and certain of its affiliated funds (collectively, “Baker Brothers”) held sole voting power with respect to an aggregate of 2,047,180 shares of the Company’s common stock, representing approximately 4% of the Company's outstanding common stock. During 2019, Baker Brothers purchased shares of the Company’s Series B1 Preferred Stock and accompanying warrants to purchase common stock in connection with the December 2019 Private Placement, as more fully described in Note 7. Concurrent with the December 2019 Private Placement, the Company amended the warrants initially issued to Baker Brothers and other holders on May 7, 2013, September 30, 2013 and February 10, 2014 to remove expiration date. Under the terms of the warrants issued to Baker Brothers and the December 2019 Securities Purchase Agreement related to the securities issued in connection with the 2019 Private Placement, Baker Brothers is not permitted to convert or exercise any common stock equivalents to the extent that such conversion or exercise would result in Baker Brothers (and its affiliates) beneficially owning more than 4.99% of the number of shares of our common stock outstanding immediately after giving effect to the issuance of shares of common stock issuable upon conversion or exercise of such securities. Baker Brothers has the right to increase this beneficial ownership limitation in its discretion on 61 days' prior written notice to us, provided that in no event is Baker Brothers permitted to convert or exercise such securities to the extent that such exercise would result in Baker Brothers (and its affiliates) beneficially owning more than 19.99% of the number of shares of our common stock outstanding immediately after giving effect to the issuance of shares of common stock issuable upon conversion or exercise of such securities. During March 2021, Baker Brothers exercised warrants to purchase 2,708,812 shares of the Company’s common stock at an exercise price of $0.08 per share for a total exercise price of approximately $0.2 million. Additionally, Pillar Investment Entities Youssef El Zein, a member of the Company’s Board of Directors until his resignation in October 2017, is a director and controlling stockholder of Pillar Invest Corporation (“Pillar Invest”), which is the general partner of Pillar Pharmaceuticals I, L.P., Pillar Pharmaceuticals II, L.P., Pillar Pharmaceuticals III, L.P., Pillar Pharmaceuticals IV, L.P., Pillar Pharmaceuticals V, L.P., Pillar 6 and Pillar Partners (collectively, the “Pillar Investment Entities”). As of December 31, 2021, the Pillar Investment Entities beneficially owned approximately 19.99% of the Company's common stock. Note 15. Related Party Transactions (Continued) During 2020, the Company sold shares of its common stock, prefunded warrants and common stock warrants to entities affiliated with Pillar Invest Corporation in connection with private placement transactions, as more fully descried in Note 8. During the year ended December 31, 2021, certain of the Pillar Investment Entities exercised warrants to purchase 3,158,386 shares of the Company’s common stock at an exercise price of $0.01 per share for a total exercise price of less than $0.1 million. 19,052 shares were used as cashless shares for the exercise costs. As of December 31, 2021, the Pillar Investment Entities held (i) prefunded warrants to purchase up to 1,533,159 shares of the Company’s common stock at an exercise price of $0.01 per share, (ii) warrants to purchase up to 3,039,514 shares of the Company’s common stock at an exercise price of $2.28 per share, (iii) warrants to purchase up to 2,764,227 shares of the Company’s common stock at an exercise price of $2.58 per share, and (iv) warrants to purchase up to 1,373,626 shares of the Company’s common stock at an exercise price of $2.71 per share. Board Fees Paid in Stock Pursuant to the Company’s director compensation program, in lieu of director board and committee fees of $0.1 million, $0.3 million, and $0.1 million, respectively, incurred during each of the years ended December 31, 2021, 2020 and 2019, respectively, the Company issued 105,691, 145,392, and 53,985 , shares of common stock, respectively, to certain of its directors. Director board and committee fees are paid in arrears and the number of shares issued was calculated based on the market closing price of the Company’s common stock on the issuance date. Officer Salary Paid in Stock In December 2020, the Company’s Chief Executive Officer was granted an award of 128,170 RSUs, pursuant to the 2013 Plan, in lieu of salary of $0.6 million pursuant to a January 10, 2020 amendment to the officers’ employment agreement. The RSUs were fully vested on the grant date. No such RSU awards were granted to any executive officers as compensation in 2021. |
Net Income (Loss) per Common Sh
Net Income (Loss) per Common Share Applicable to Common Stockholders | 12 Months Ended |
Dec. 31, 2021 | |
Net Income (Loss) per Common Share Applicable to Common Stockholders | |
Net Income (Loss) per Common Share Applicable to Common Stockholders | Note 16. Net Income (Loss) per Common Share Applicable to Common Stockholders Details in the computation of basic and diluted net income (loss) per common share were as follows: Year Ended December 31, ($ in thousands except per share data) 2021 2020 2019 Net income (loss) applicable to common stockholders — Basic: Net income (loss) $ 98,091 $ (112,662) $ (56,515) Less: Deemed dividend on preferred stock — — (28,043) Less: Undistributed earnings to preferred stockholders (1,150) — — Net income (loss) applicable to common stockholders - basic $ 96,941 $ (112,662) $ (84,558) Numerator for basic net income (loss) applicable to common stockholders $ 96,941 $ (112,662) $ (84,558) Denominator for basic net income (loss) applicable to common stockholders 49,203 33,821 28,545 Net income (loss) applicable to common stockholders - basic $ 1.97 $ (3.33) $ (2.96) Net loss applicable to common stockholders — Diluted: Net income (loss) $ 96,941 $ (112,662) $ (84,558) Less: Warrant revaluation gain applicable to dilutive liability-classified warrants (6,983) — — Less: Future tranche right revaluation gain applicable to dilutive liability-classified future tranche rights (118,803) — — Numerator for diluted net income (loss) applicable to common stockholders $ (28,845) $ (112,662) $ (84,558) Denominator for basic net income (loss) applicable to common stockholders 49,203 33,821 28,545 Plus: Incremental shares underlying “in the money” liability-classified warrants outstanding 93 — — Plus: Incremental shares underlying “in the money” liability-classified future tranche rights outstanding 831 — — Denominator for diluted net income (loss) applicable to common stockholders 50,127 33,821 28,545 Net income (loss) applicable to common stockholders - diluted $ (0.58) $ (3.33) $ (2.96) T otal antidilutive securities excluded from the calculation of diluted net loss per share for the years ended December 31, , were as follows: (in thousands) 2021 2020 2019 Stock options 5,202 4,614 4,220 Restricted stock units 576 903 194 Common stock warrants 8,732 16,968 5,099 Convertible preferred stock — 2,369 2,369 Future tranche rights — 50,467 49,407 Total 14,510 75,321 61,289 |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2021 | |
Subsequent Events | |
Subsequent Events | Note 17. Subsequent Events The Company considers events or transactions that occur after the balance sheet date but prior to the issuance of the financial statements to provide additional evidence relative to certain estimates or to identify matters that require additional disclosure. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Summary of Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation The accompanying financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”). |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates, judgements, and assumptions that affect the reported amounts of assets, liabilities, equity, revenues and expenses, and related disclosure of contingencies in the accompanying financial statements and these notes. In addition, management’s assessment of the Company’s ability to continue as a going concern involves the estimation of the amount and timing of future cash inflows and outflows. On an ongoing basis, the Company evaluates its estimates, judgments and methodologies. The Company bases its estimates on historical experience and on various other assumptions that are believed to be reasonable. Actual results could differ materially from those estimates. |
Segment Information | Segment Information Operating segments are defined as components of an enterprise in which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and assessing performance. The Company views its operations and manages its business as one operating segment, which is the business of developing novel therapeutics for rare diseases and oncology. |
Financial Instruments | Financial Instruments The fair value of the Company’s financial instruments is determined and disclosed in accordance with the three-tier fair value hierarchy specified in Note 3. The Company is required to disclose the estimated fair values of its financial instruments. As of December 31, 2021, the Company’s financial instruments consisted of cash and cash equivalents. As of December 31, 2020, the Company’s financial instruments consisted of cash, cash equivalents, short-term investments, and warrant and future tranche right liabilities. The estimated fair values of these financial instruments approximate their carrying values as of December 31, 2021 and 2020. As of December 31, 2021, the Company did not have any other derivatives, hedging instruments or other similar financial instruments. |
Concentration of Credit Risk | Concentration of Credit Risk Financial instruments that subject the Company to credit risk primarily consist of cash, cash equivalents and short-term investments. The Company’s credit risk is managed by investing in highly rated money market instruments, U.S. treasury bills, corporate bonds, commercial paper and/or other debt securities. Due to these factors, no significant additional credit risk is believed by management to be inherent in the Company’s assets. As of December 31, 2021, all of the Company’s cash and cash equivalents were held at two financial institutions. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments with maturities of 90 days or less when purchased to be “cash equivalents.” Cash and cash equivalents at December 31, 2021 consisted of cash and money market funds. Cash and cash equivalents at December 31, 2020 consisted of cash and cash equivalents and short-term investments. |
Property and Equipment | Property and Equipment Property and equipment are carried at acquisition cost less accumulated depreciation, subject to review for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable as described further under the heading "Impairment of Long-Lived Assets" below. The cost of normal, recurring, or periodic repairs and maintenance activities related to property and equipment are expensed as incurred. The cost for planned major maintenance activities, including the related acquisition or construction of assets, is capitalized if the repair will result in future economic benefits. Depreciation and amortization are computed using the straight-line method based on the estimated useful lives of the related assets. Leasehold improvements are amortized over the remaining lease term or the related useful life, if shorter. Equipment and other long-lived assets are depreciated over three When an asset is disposed of, the associated cost and accumulated depreciation is removed from the related accounts on the Company's balance sheet with any resulting gain or loss included in the Company's statement of operations. |
Operating Lease Right-of-use Asset and Lease Liability | Operating Lease Right-of-use Asset and Lease Liability The Company accounts for leases under ASC 842, Leases Property, Plant, and Equipment As of December 31, 2021 and 2020, the Company’s operating lease ROU assets and corresponding short-term and long-term lease liabilities primarily relate to its existing Exton, Pennsylvania facility operating lease, which expires on May 31, 2025. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets In accordance with ASC 360-10-35, Impairment or Disposal of Long-Lived Assets |
Other Current Liability | Other Current Liability In October 2020, the Company entered into a short-term financing arrangement with a third-party vendor to finance insurance premiums. The aggregate amount financed under this agreement was |
Warrant Liability | Warrant Liability The Company accounts for stock warrants as either equity instruments, liabilities or derivative liabilities in accordance with ASC 480, Distinguishing Liabilities from Equity Derivatives and Hedging |
Future Tranche Right Liability | Future Tranche Right Liability On December 23, 2019, the Company entered into a Securities Purchase Agreement (the “December 2019 Securities Purchase Agreement”) with institutional investors affiliated with Baker Brothers (the “Purchasers”), an existing stockholder and related party (see Note 15). As more fully described in Note 7, the December 2019 Securities Purchase Agreement contained call options on redeemable preferred shares with warrants (conditionally exercisable for shares that are puttable). The Company determined that these call options represent freestanding financial instruments and accounts for the options as liabilities (“Future Tranche Right Liability”) under ASC 480, which requires the measurement and recognition of the fair value of the liability at the time of issuance and at each reporting period. Any change in fair value is recognized in Future Tranche Right Liability Revaluation (Loss) Gain in the Company’s statements of operations. As of December 31, 2020, the Future Tranche Right Liability was classified as a long-term liability in the Company’s balance sheet as settlement is in the form of the applicable Series B convertible preferred stock and warrants exercisable for shares of either Series B1 Preferred Stock or the Company’s common stock. During the three months ended March 31, 2021, the liability-classified call options provided for under the December 2019 Securities Purchase Agreement terminated and, accordingly, the liability balance was derecognized. For additional discussion on the Future Tranche Right Liability, see Note 7. |
Preferred Stock | Preferred Stock The Company applies ASC 480 when determining the classification and measurement of its preferred stock. Preferred shares subject to mandatory redemption are classified as liability instruments and are measured at fair value. Conditionally redeemable preferred shares (including preferred shares that feature redemption rights that are either within the control of the holder or subject to redemption upon the occurrence of uncertain events not solely within the Company’s control) are classified as temporary equity. At all other times, preferred shares are classified as stockholders’ equity. Accretion of redeemable convertible preferred stock includes the accretion of the Company's Series B redeemable convertible preferred stock to its stated value. The carrying value of the Series B redeemable convertible preferred stock is being accreted to redemption value using the effective interest method, from the date of issuance to the earliest date the holders can demand redemption or until the redeemable convertible preferred stock ceases to be outstanding. |
Redeemable Preferred Stock Issued with Other Freestanding Instruments | Redeemable Preferred Stock Issued with Other Freestanding Instruments The Company considers guidance within ASC 470-20, Debt |
Revenue Recognition | Revenue Recognition The Company recognizes revenue in accordance with ASC 606, Revenue from Contracts with Customers (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it determines that it is probable it will collect the consideration to which it is entitled in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Amounts received prior to satisfying the revenue recognition criteria are recognized as deferred revenue in the Company’s balance sheet. Amounts expected to be recognized as revenue within the 12 months following the balance sheet date are classified as current portion of deferred revenue. Amounts not expected to be recognized as revenue within the 12 months following the balance sheet date are classified as deferred revenue, net of current portion. Alliance Revenues The Company’s revenues have primarily been generated through collaborative research, development and/or commercialization agreements. The terms of these agreements may include payment to the Company of one or more of the following: nonrefundable, up-front license fees; research, development and commercial milestone payments; and other contingent payments due based on the activities of the counterparty or the reimbursement by licensees of costs associated with patent maintenance. Each of these types of revenue are recorded as Alliance revenues in the Company’s statements of operations. See Note 10, “Collaboration and License Agreements” for additional details regarding the Company’s collaboration and out-licensing arrangements. |
Research and Development Prepayments, Accruals and Related Expenses | Research and Development Prepayments, Accruals and Related Expenses All research and development expenses are expensed as incurred. Research and development expenses are comprised of costs incurred in performing research and development activities, including drug development trials and studies, research collaborations, drug manufacturing, laboratory supplies, external research, payroll including stock-based compensation and overhead. The Company is required to estimate our accrued and prepared expenses for research and development activities performed by third parties, including Clinical Research Organizations (“CRO’s”) and clinical investigators. These estimates are made as of the reporting date of the work completed over the life of the individual study in accordance with agreements established with CRO’s and other clinical sites. Some CRO’s invoice the Company on a monthly basis, while others invoice upon the achievement of milestones. The Company determines the estimates of research and development activities incurred at the end of each reporting period through discussion with internal personnel, outside service providers, and research collaboration partners as to the progress or stage of completion of trials or services, as of the end of the reporting period, pursuant to contracts with clinical trial centers or CRO’s and the agreed upon fee to be paid for such services. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are deferred and capitalized. The capitalized amounts are expensed as the related goods are accepted by the Company or the services are performed. As of December 31, 2021 and 2020, the Company recorded approximately |
Stock-Based Compensation | Stock-Based Compensation The Company accounts for stock-based compensation using ASC 718, Compensation – Stock Compensation Equity – Equity Based Payments to Non-Employees The Company recognizes all share-based payments to employees and directors as expense in the statements of operations based on their fair values. The Company records compensation expense on a straight-line basis over an award’s requisite service period, or vesting period, based on the award’s fair value at the date of grant. Vesting for time-based options and restricted stock units is generally four years for employees and one year for directors. The Company uses a Black-Scholes option-pricing model to determine the fair value of each option grant as of the date of grant for expense incurred. The Black-Scholes option pricing model requires inputs for risk-free interest rate, dividend yield, expected stock price volatility and expected term of the options. Forfeitures are accounted for as they occur. See Note 11, “Stock-based Compensation” for additional details. |
Income Taxes | Income Taxes An asset and liability approach is used for financial accounting and reporting for income taxes. Deferred income taxes arise from temporary differences between income tax and financial reporting and principally relate to recognition of revenue and expenses in different periods for financial and tax accounting purposes and are measured using currently enacted tax rates and laws. In addition, a deferred tax asset can be generated by a net operating loss carryover. If it is more likely than not that some portion or all of a deferred tax asset will not be realized, a valuation allowance is recognized. In the event the Company is charged interest or penalties related to income tax matters, the Company would record such interest as interest expense and would record such penalties as other expense in the Statements of Operations. No such charges have been incurred by the Company. For each of the years ended December 31, 2021, 2020 and 2019, the Company had no uncertain tax positions. See Note 13, “Income Taxes” for additional details. |
Net Income (Loss) per Common Share applicable to Common Stockholders | Net Income (Loss) per Common Share applicable to Common Stockholders The Company uses the two-class method to compute net income per common share during periods the Company realizes net income and has securities outstanding (e.g. redeemable convertible preferred stock) that entitle the holder to participate in dividends and earnings of the Company. In addition, the Company analyzes the potential dilutive effect of outstanding redeemable convertible preferred stock under the "if-converted" method when calculating diluted earnings per share and reports the more dilutive of the approaches (two class or "if-converted"). The two-class method is not applicable during periods with a net loss, as the holders of the redeemable convertible preferred stock have no obligation to fund losses. The Company also analyzes the potential dilutive effect of outstanding stock options, unvested restricted stock units, warrants and shares underlying future tranche rights under the treasury stock method (as applicable), during periods of income, or during periods in which income is recognized related to changes in fair value of its liability-classified securities. |
New Accounting Pronouncements | New Accounting Pronouncements From time to time, new accounting pronouncements are issued by the FASB and rules are issued by the SEC that the Company has or will adopt as of a specified date. Unless otherwise noted, management does not believe that any other recently issued accounting pronouncements issued by the FASB or guidance issued by the SEC had, or is expected to have, a material impact on the Company’s present or future financial statements. Recently Adopted Accounting Pronouncements In June 2016, the FASB issued Accounting Standard Update (“ASU”) No. 2016-13, Financial Instruments Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments In August 2018, the FASB issued ASU No. 2018-13, Disclosure Framework Changes to the Disclosure Requirements for Fair Value Measurement Fair Value Measurement In August 2020, the FASB issued ASU No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06”), which simplifies the guidance on an issuer’s accounting for convertible instruments and contracts in its own equity. The Company adopted ASU 2020-06 in the first quarter of 2021. The adoption of this ASU did not have a material effect on the Company’s financial statements. |
Accounting for Uncertainty in Income Taxes | The Company applies ASC 740-10, Accounting for Uncertainty in Income Taxes, an interpretation of ASC 740 |
COVID-19 | COVID-19 While the Company is not aware of a material impact from the continuation of the coronavirus ("COVID-19") pandemic through December 31, 2021, the full extent to which the COVID-19 pandemic will directly or indirectly impact the Company’s business, results of operations, and financial condition, depends on future developments. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Measurements | |
Schedule of assets and liabilities measured and recorded in financial statements at fair value on a recurring basis | December 31, 2021 (In thousands) Total Level 1 Level 2 Level 3 Assets Cash $ 250 $ 250 $ — $ — Cash equivalents – money market funds 32,295 32,295 — — Total assets $ 32,545 $ 32,545 $ — $ — December 31, 2020 (In thousands) Total Level 1 Level 2 Level 3 Assets Cash $ 250 $ 250 $ — $ — Cash equivalents – money market funds 32,979 32,979 — — Short-term investments – commercial paper 3,499 — 3,499 — Short-term investments – US treasury bills 1,000 — 1,000 — Total assets $ 37,728 $ 33,229 $ 4,499 $ — Liabilities Warrant liability $ 6,983 $ — $ — $ 6,983 Future tranche right liability 118,803 — — 118,803 Total liabilities $ 125,786 $ — $ — $ 125,786 |
Schedule of reconciliation measured at fair value on a recurring basis using unobservable inputs | Future Warrant Tranche Right (In thousands) Liability Liability Balance, December 31, 2019 $ 3,241 $ 46,436 Change in the fair value of liability 3,742 72,367 Balance, December 31, 2020 $ 6,983 $ 118,803 Change in the fair value of liability (1) (6,983) (118,803) Balance, December 31, 2021 $ — $ — (1) During the year ended December 31, 2021, the Company’s liability-classified warrants and future tranche rights terminated, and accordingly, the liabilities were derecognized. See Notes 7 and 8. |
Warrant liability | |
Fair Value Measurements | |
Schedule of assumptions used in determining fair value | December 31, December 31, 2020 2019 Risk-free interest rate 0.50% 1.79% Expected dividend yield — — Expected term (years) 5.98 6.98 Expected volatility 80% 80% Exercise price (per share) $ 1.52 $ 1.52 |
Future tranche right liability | |
Fair Value Measurements | |
Schedule of assumptions used in determining fair value | December 31, December 31, 2020 2019 Risk-free interest rate 0.64% - 0.73% 1.84% - 1.88% Expected dividend yield — — Expected term (years) of call options on preferred stock 0.25 - 1.12 1.16 - 2.16 Expected term (years) of warrants 7.25 - 8.12 8.16 - 9.16 Expected volatility 80% 80% Exercise price (per share) for common stock equivalent for preferred stock and warrant $ 1.52 - 1.82 $ 1.52 - 1.82 |
Investments (Tables)
Investments (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Investments | |
Schedule of available-for-sale investments at fair value | December 31, 2020 Gross Gross Estimated Unrealized Unrealized Fair (In thousands) Cost (Losses) Gains Value Short-term investments – commercial paper $ 3,499 $ — $ — $ 3,499 Short-term investments – US treasury bills 1,000 — — 1,000 Total short-term investments $ 4,499 $ — $ — $ 4,499 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Property and Equipment | |
Schedule of net property and equipment at cost | December 31, December 31, (In thousands) 2021 2020 Leasehold improvements $ 107 $ 107 Equipment and other 712 770 Total property and equipment, at cost $ 819 $ 877 Less: Accumulated depreciation and amortization 797 833 Property and equipment, net $ 22 $ 44 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Accrued Expenses | |
Schedule of accrued expenses | December 31, December 31, (In thousands) 2021 2020 Payroll and related costs $ 477 $ 2,133 Clinical and nonclinical trial expenses 2,909 3,229 Professional and consulting fees 591 584 Other 111 126 Total accrued expenses $ 4,088 $ 6,072 |
Stockholders' Equity (Deficit)
Stockholders' Equity (Deficit) (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Stockholders' Equity (Deficit) | |
Schedule of warrants outstanding and exercisable for purchase of common stock | Number of Shares December 31, December 31, Weighted-Average Description 2021 2020 Exercise Price Expiration Date Liability-classified Warrants December 2019 Series B1 warrants (1) — 2,368,400 $ 1.52 Dec 2026 — 2,368,400 Equity-classified Warrants May 2013 warrants 15,437 1,949,754 $ 0.08 None September 2013 warrants 4,096 514,756 $ 0.08 None February 2014 warrants 2,171 266,006 $ 0.08 None April 2020 Private Placement first closing warrants 3,039,514 3,039,514 $ 2.28 Apr 2023 April 2020 Private Placement second closing warrants 1,373,626 1,373,626 $ 2.71 Dec 2023 April 2020 Private Placement second closing warrants 1,143,428 2,677,311 $ 0.01 None July 2020 Private Placement first closing warrants 389,731 2,014,234 $ 0.01 None July 2020 Private Placement first closing warrants 2,764,227 2,764,227 $ 2.58 Jul 2023 8,732,230 14,599,428 Total outstanding 8,732,230 16,967,828 (1) The Series B1 warrants were exercisable for either common stock (exercise price of $1.52 ) or Series B1 Convertible Preferred Stock (exercise price of $152 ) at the discretion of the warrant holder. However, as more fully disclosed in Note 7, the December 2019 Series B1 warrants were terminated during the three months ended March 31, 2021 contemporaneously with the termination of the future tranche rights. |
Summary of warrant activity | Number of Weighted-Average Warrants Exercise Price Outstanding at December 31, 2020 16,967,828 $ 1.28 Issued — — Exercised (1) (5,867,198) 0.04 Expired (2,368,400) 1.52 Outstanding at December 31, 2021 8,732,230 $ 2.04 (1) During th e year ended December 31, 2021, certain related parties were issued warrants as more fully described in Note 15. |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Stock-Based Compensation | |
Schedule of stock-based compensation expense attributable to share-based payments made to employees and directors and included in operating expenses | (in thousands) 2021 2020 2019 Stock-based compensation: Research and development Employee Stock Purchase Plan $ 28 $ 88 $ 36 Equity Incentive Plan 546 673 1,312 $ 574 $ 761 $ 1,348 General and administrative Employee Stock Purchase Plan $ 3 $ 9 $ 20 Equity Incentive Plan 1,960 2,871 2,477 $ 1,963 $ 2,880 $ 2,497 Total stock-based compensation expense $ 2,537 $ 3,641 $ 3,845 |
Schedule of weighted average assumptions applied to options | 2021 2020 2019 Average risk-free interest rate 0.4% 1.0% 2.1% Expected dividend yield — — — Expected lives (years) 3.6 3.9 3.7 Expected volatility 94% 84% 84% Weighted average exercise price (per share) $ 2.68 $ 2.08 $ 2.75 |
Schedule of information related to outstanding and exercisable options | ($ in thousands, except per share data) Stock Options Weighted-Average Exercise Price Weighted-Average Remaining Contractual Life (in years) Aggregate Intrinsic Value Outstanding at December 31, 2020 4,614,323 $ 9.78 6.8 $ 2,949 Granted 1,356,700 2.68 Exercised (22,500) 2.11 Forfeited (261,426) 4.44 Expired (485,091) 11.52 Outstanding at December 31, 2021 (1) 5,202,006 $ 8.06 5.9 $ — Exercisable at December 31, 2021 4,096,875 $ 9.62 5.1 $ — (1) Includes both vested stock options as well as unvested stock options for which the requisite service period has not been rendered but that are expected to vest based on achievement of a service condition. |
Schedule of summary of restricted stock activity | Time-based Awards Market/Performance-based Awards ($ in thousands, except per share data) Number of Shares Weighted-Average Grant Date Fair Value Number of Shares Weighted-Average Grant Date Fair Value Nonvested shares at December 31, 2020 354,003 $ 2.27 549,318 $ 1.54 Granted Cancelled (48,563) 2.31 (42,290) 1.54 Vested (236,765) 2.25 — — Nonvested shares at December 31, 2021 68,675 $ 2.30 507,028 $ 1.54 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies | |
Schedule of Future Minimum Rental Payments for Operating Leases [Table Text Block] | December 31, Operating Leases (in thousands) 2022 249 2023 250 2024 240 2025 101 $ 840 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Taxes | |
Schedule of components of deferred tax assets | (in thousands) 2021 2020 Operating loss carryforwards $ 90,550 $ 90,895 Tax credit carryforwards 28,226 26,550 Stock-based compensation 6,902 6,820 Capitalized research and development 7,818 — Lease liabilities 220 276 Other 70 162 Total deferred tax assets 133,786 124,703 Right-of-use asset (213) (270) Valuation allowance (133,573) (124,433) Net deferred tax assets $ — $ — |
Schedule of difference between U.S. federal corporate tax rate and Company effective tax rate | 2021 2020 2019 Expected federal income tax rate (21.0) % (21.0) % (21.0) % Expiring credits and NOLs — — — Change in valuation allowance (9.3) 10.6 26.2 Federal and state credits 1.7 (3.1) (8.1) State income taxes, net of federal benefit 2.1 (1.9) (4.7) Warrant and future tranche right revaluation loss 26.9 14.2 4.3 Stock-based compensation — 0.2 0.5 Other (0.4) 1.0 2.8 Effective tax rate 0.0 % 0.0 % 0.0 % |
Net Income (Loss) per Common _2
Net Income (Loss) per Common Share Applicable to Common Stockholders (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Net Income (Loss) per Common Share Applicable to Common Stockholders | |
Computation of basic and diluted net income (loss) per share | Year Ended December 31, ($ in thousands except per share data) 2021 2020 2019 Net income (loss) applicable to common stockholders — Basic: Net income (loss) $ 98,091 $ (112,662) $ (56,515) Less: Deemed dividend on preferred stock — — (28,043) Less: Undistributed earnings to preferred stockholders (1,150) — — Net income (loss) applicable to common stockholders - basic $ 96,941 $ (112,662) $ (84,558) Numerator for basic net income (loss) applicable to common stockholders $ 96,941 $ (112,662) $ (84,558) Denominator for basic net income (loss) applicable to common stockholders 49,203 33,821 28,545 Net income (loss) applicable to common stockholders - basic $ 1.97 $ (3.33) $ (2.96) Net loss applicable to common stockholders — Diluted: Net income (loss) $ 96,941 $ (112,662) $ (84,558) Less: Warrant revaluation gain applicable to dilutive liability-classified warrants (6,983) — — Less: Future tranche right revaluation gain applicable to dilutive liability-classified future tranche rights (118,803) — — Numerator for diluted net income (loss) applicable to common stockholders $ (28,845) $ (112,662) $ (84,558) Denominator for basic net income (loss) applicable to common stockholders 49,203 33,821 28,545 Plus: Incremental shares underlying “in the money” liability-classified warrants outstanding 93 — — Plus: Incremental shares underlying “in the money” liability-classified future tranche rights outstanding 831 — — Denominator for diluted net income (loss) applicable to common stockholders 50,127 33,821 28,545 Net income (loss) applicable to common stockholders - diluted $ (0.58) $ (3.33) $ (2.96) |
Schedule of potentially dilutive securities excluded from diluted net income (loss) per common share | (in thousands) 2021 2020 2019 Stock options 5,202 4,614 4,220 Restricted stock units 576 903 194 Common stock warrants 8,732 16,968 5,099 Convertible preferred stock — 2,369 2,369 Future tranche rights — 50,467 49,407 Total 14,510 75,321 61,289 |
Business and Organization (Deta
Business and Organization (Details) $ in Thousands | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2021person | Dec. 31, 2021USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2020USD ($) | |
Business and Organization | ||||
Percentage of positions eliminated | 50.00% | |||
Restructuring and Related Cost, Number of Positions Eliminated | person | 17 | |||
Restructuring costs | $ 1,322 | $ 181 | ||
Accumulated deficit | 735,461 | $ 833,552 | ||
Cash, cash equivalents and investments | $ 32,500 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Details) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2021USD ($)Institutionsegment | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Oct. 31, 2020USD ($) | |
Accounting Policies | ||||
Number of operating segments | segment | 1 | |||
Number of financial institutions | Institution | 2 | |||
Short-term financing arrangement | $ 600 | |||
Other current liability | $ 0 | $ 435 | ||
Prepaid expenses research and development | 900 | 2,500 | ||
Charges incurred | 0 | 0 | $ 0 | |
Uncertain tax positions | $ 0 | $ 0 | $ 0 | |
Minimum [Member] | ||||
Accounting Policies | ||||
Equipment depreciation period | 3 years | |||
Maximum [Member] | ||||
Accounting Policies | ||||
Equipment depreciation period | 5 years | |||
Employees | ||||
Accounting Policies | ||||
Stock options, vesting period | 4 years | |||
Directors [Member] | ||||
Accounting Policies | ||||
Stock options, vesting period | 1 year |
Fair Value Measurements - Trans
Fair Value Measurements - Transfers Between Levels (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Fair Value Measurements | |
Fair value of assets transfers from level 1 to level 2 | $ 0 |
Fair value of assets transfers from level 2 to level 1 | 0 |
Fair value of liabilities transfers from level 1 to level 2 | 0 |
Fair value of liabilities transfers from level 2 to level 1 | 0 |
Fair value of assets transfers into level 3 | 0 |
Fair value of assets transfers out of level 3 | 0 |
Fair value of liabilities transfers into level 3 | 0 |
Fair value of liabilities transfers out of level 3 | $ 0 |
Fair Value Measurements - Asset
Fair Value Measurements - Assets and Liabilities at Fair Value on Recurring Basis (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Fair Value of Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||
Cash equivalents and Short-term investments | $ 4,499 | |
Fair Value, Measurements, Recurring [Member] | ||
Fair Value of Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||
Total Assets | $ 32,545 | 37,728 |
Total Liabilities | 125,786 | |
Fair Value, Measurements, Recurring [Member] | Warrant liability | ||
Fair Value of Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||
Total Liabilities | 6,983 | |
Fair Value, Measurements, Recurring [Member] | Future tranche right liability | ||
Fair Value of Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||
Total Liabilities | 118,803 | |
Fair Value, Measurements, Recurring [Member] | Cash | ||
Fair Value of Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||
Cash and Money market funds | 250 | 250 |
Fair Value, Measurements, Recurring [Member] | Money Market Funds [Member] | ||
Fair Value of Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||
Cash and Money market funds | 32,295 | 32,979 |
Fair Value, Measurements, Recurring [Member] | Short-term investments - commercial paper | ||
Fair Value of Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||
Cash equivalents and Short-term investments | 3,499 | |
Fair Value, Measurements, Recurring [Member] | Short-term investments - U.S. treasury bills | ||
Fair Value of Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||
Cash equivalents and Short-term investments | 1,000 | |
Quoted Prices in Active Markets for Identical Assets or Liabilities (Level 1) [Member] | Fair Value, Measurements, Recurring [Member] | ||
Fair Value of Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||
Total Assets | 32,545 | 33,229 |
Quoted Prices in Active Markets for Identical Assets or Liabilities (Level 1) [Member] | Fair Value, Measurements, Recurring [Member] | Cash | ||
Fair Value of Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||
Cash and Money market funds | 250 | 250 |
Quoted Prices in Active Markets for Identical Assets or Liabilities (Level 1) [Member] | Fair Value, Measurements, Recurring [Member] | Money Market Funds [Member] | ||
Fair Value of Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||
Cash and Money market funds | $ 32,295 | 32,979 |
Significant Other Observable Inputs (Level 2) [Member] | Fair Value, Measurements, Recurring [Member] | ||
Fair Value of Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||
Total Assets | 4,499 | |
Significant Other Observable Inputs (Level 2) [Member] | Fair Value, Measurements, Recurring [Member] | Short-term investments - commercial paper | ||
Fair Value of Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||
Cash equivalents and Short-term investments | 3,499 | |
Significant Other Observable Inputs (Level 2) [Member] | Fair Value, Measurements, Recurring [Member] | Short-term investments - U.S. treasury bills | ||
Fair Value of Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||
Cash equivalents and Short-term investments | 1,000 | |
Significant Unobservable Inputs (Level 3) [Member] | Fair Value, Measurements, Recurring [Member] | ||
Fair Value of Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||
Total Liabilities | 125,786 | |
Significant Unobservable Inputs (Level 3) [Member] | Fair Value, Measurements, Recurring [Member] | Warrant liability | ||
Fair Value of Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||
Total Liabilities | 6,983 | |
Significant Unobservable Inputs (Level 3) [Member] | Fair Value, Measurements, Recurring [Member] | Future tranche right liability | ||
Fair Value of Assets and Liabilities Measured at Fair Value on a Recurring Basis | ||
Total Liabilities | $ 118,803 |
Fair Value Measurements - Ass_2
Fair Value Measurements - Assets and Liabilities at Fair Value Changes in Level 3 Liabilities (Details) - Fair Value, Measurements, Recurring [Member] - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Warrant liability | |||
Fair Value of Assets and Liabilities Measured at Fair Value on a Recurring Basis | |||
Beginning balance | $ 6,983 | ||
Change in the fair value of liability | (6,983) | $ 3,742 | $ 3,241 |
Ending balance | 6,983 | ||
Future tranche right liability | |||
Fair Value of Assets and Liabilities Measured at Fair Value on a Recurring Basis | |||
Beginning balance | 118,803 | ||
Change in the fair value of liability | $ (118,803) | 72,367 | $ 46,436 |
Ending balance | $ 118,803 |
Fair Value Measurements - Weigh
Fair Value Measurements - Weighted-average assumptions (Details) | Dec. 31, 2021$ / shares | Dec. 31, 2020$ / shares |
Risk-free interest rate | ||
Fair Value Measurement Inputs and Valuation Techniques | ||
Debt instrument measurement input | 0.0050 | 0.0179 |
Expected term | ||
Fair Value Measurement Inputs and Valuation Techniques | ||
Debt instrument measurement input | 0.0598 | 0.0698 |
Expected volatility | ||
Fair Value Measurement Inputs and Valuation Techniques | ||
Debt instrument measurement input | 0.80 | 0.80 |
Exercise price | ||
Fair Value Measurement Inputs and Valuation Techniques | ||
Debt instrument measurement input | 1.52 | 1.52 |
Fair Value Measurements - Futur
Fair Value Measurements - Future Tranche Rights (Details) | Dec. 31, 2021$ / sharesUSD ($) | Dec. 31, 2020$ / shares |
Risk-free interest rate | ||
Fair Value Measurement Inputs and Valuation Techniques | ||
Debt instrument measurement input | 0.0050 | 0.0179 |
Risk-free interest rate | Minimum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques | ||
Debt instrument measurement input | 0.64 | |
Risk-free interest rate | Future tranche right liability | Maximum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques | ||
Debt instrument measurement input | 0.73 | |
Risk-free interest rate | Preferred stock | Minimum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques | ||
Debt instrument measurement input | 1.84 | |
Risk-free interest rate | Preferred stock | Maximum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques | ||
Debt instrument measurement input | 1.88 | |
Expected dividend yield | Future tranche right liability | Maximum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques | ||
Debt instrument measurement input | 1.12 | |
Expected term | ||
Fair Value Measurement Inputs and Valuation Techniques | ||
Debt instrument measurement input | 0.0598 | 0.0698 |
Expected term | Minimum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques | ||
Debt instrument measurement input | 0.25 | |
Expected term | Future tranche right liability | Maximum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques | ||
Debt instrument measurement input | 8.12 | |
Expected term | Warrants | Minimum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques | ||
Debt instrument measurement input | 7.25 | 8.16 |
Expected term | Warrants | Maximum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques | ||
Debt instrument measurement input | 9.16 | |
Expected term | Preferred stock | Minimum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques | ||
Debt instrument measurement input | 1.16 | |
Expected term | Preferred stock | Maximum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques | ||
Debt instrument measurement input | 2.16 | |
Expected volatility | ||
Fair Value Measurement Inputs and Valuation Techniques | ||
Debt instrument measurement input | 0.80 | 0.80 |
Expected volatility | Future tranche right liability | ||
Fair Value Measurement Inputs and Valuation Techniques | ||
Debt instrument measurement input | 80 | 80 |
Exercise price | ||
Fair Value Measurement Inputs and Valuation Techniques | ||
Debt instrument measurement input | $ / shares | 1.52 | 1.52 |
Exercise price | Future tranche right liability | Minimum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques | ||
Debt instrument measurement input | 1.52 | 1.52 |
Exercise price | Future tranche right liability | Maximum [Member] | ||
Fair Value Measurement Inputs and Valuation Techniques | ||
Debt instrument measurement input | 1.82 | 1.82 |
Investments - Summary of Availa
Investments - Summary of Available-for-Sale Investments at Fair Value (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Schedule of Available-for-sale Securities | ||
Cost | $ 4,499 | |
Estimated Fair Value | $ 0 | 4,499 |
Short-term investments - commercial paper | ||
Schedule of Available-for-sale Securities | ||
Cost | 3,499 | |
Estimated Fair Value | 3,499 | |
US Treasury Bill Securities [Member] | ||
Schedule of Available-for-sale Securities | ||
Cost | 1,000 | |
Estimated Fair Value | $ 1,000 |
Investments (Details)
Investments (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Investments | ||
Realized gains or losses | $ 0 | $ 0 |
Allowance for credit losses on available-for-sale debt securities | 0 | |
Losses or other-than-temporary declines | $ 0 | $ 0 |
Property and Equipment - Net Pr
Property and Equipment - Net Property and Equipment at Cost (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Property, Plant and Equipment | ||
Total property and equipment, at cost | $ 819 | $ 877 |
Less: Accumulated depreciation and amortization | 797 | 833 |
Property and equipment, net | 22 | 44 |
Leasehold improvements | ||
Property, Plant and Equipment | ||
Total property and equipment, at cost | 107 | 107 |
Laboratory equipment and other | ||
Property, Plant and Equipment | ||
Total property and equipment, at cost | $ 712 | $ 770 |
Property and Equipment - Deprec
Property and Equipment - Depreciation and Amortization Expense (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Property and Equipment | |||
Depreciation and amortization expense on property and equipment | $ 0.1 | $ 0.1 | $ 0.1 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Accrued Expenses | ||
Payroll and related costs | $ 477 | $ 2,133 |
Clinical and nonclinical trial expenses | 2,909 | 3,229 |
Professional and consulting fees | 591 | 584 |
Other | 111 | 126 |
Total accrued expenses | $ 4,088 | $ 6,072 |
Redeemable Convertible Prefer_2
Redeemable Convertible Preferred Stock (Details) - USD ($) $ / shares in Units, $ in Thousands | Dec. 23, 2019 | Mar. 31, 2021 | Dec. 31, 2019 | Dec. 31, 2021 | Dec. 31, 2019 | Dec. 31, 2020 |
Temporary Equity | ||||||
Warrant exercised price (per share) | $ 2.04 | $ 1.28 | ||||
Aggregate gross proceeds | $ 3,900 | $ 10,072 | ||||
Gross proceeds | $ 6,200 | |||||
Common Stock, Shares Authorized | 140,000,000 | 140,000,000 | 140,000,000 | 140,000,000 | ||
Baker Bros. Advisors LP [Member] | ||||||
Temporary Equity | ||||||
Warrant exercised price (per share) | $ 0.08 | |||||
Deemed Dividend | 28,000 | |||||
Series B1 Warrants | ||||||
Temporary Equity | ||||||
Gross proceeds received | 10,100 | |||||
Estimated fair values | 2,600 | |||||
Future Tranche Rights | ||||||
Temporary Equity | ||||||
Estimated fair values | $ 35,500 | |||||
Series B1 Redeemable Convertible Preferred Stock | ||||||
Temporary Equity | ||||||
Sale of redeemable convertible preferred stock | 23,684 | 24,000 | ||||
Conversion of preferred stock to common, shares | 23,684 | |||||
Series B1 Redeemable Convertible Preferred Stock | Baker Bros. Advisors LP [Member] | ||||||
Temporary Equity | ||||||
Conversion of preferred stock to common, shares | 14,150 | |||||
Series B1 Redeemable Convertible Preferred Stock | Common Stock Warrants | ||||||
Temporary Equity | ||||||
Warrant to purchase stock | 2,368,400 | |||||
Warrant exercised price (per share) | $ 1.52 | |||||
Series B1 Redeemable Convertible Preferred Stock | Preferred Stock Warrant | ||||||
Temporary Equity | ||||||
Warrant to purchase stock | 23,684 | |||||
Warrant exercised price (per share) | $ 152 | |||||
Series B2 Redeemable Convertible Preferred Stock | ||||||
Temporary Equity | ||||||
Aggregate gross proceeds | $ 15,000 | |||||
Preferred Shares | 98,685 | |||||
Series B2 Redeemable Convertible Preferred Stock | Common Stock Warrants | ||||||
Temporary Equity | ||||||
Warrant to purchase stock | 9,868,500 | |||||
Warrant exercised price (per share) | $ 1.52 | |||||
Series B2 Redeemable Convertible Preferred Stock | Preferred Stock Warrant | ||||||
Temporary Equity | ||||||
Warrant to purchase stock | 98,685 | |||||
Warrant exercised price (per share) | $ 152 | |||||
Series B3 Redeemable Convertible Preferred Stock | ||||||
Temporary Equity | ||||||
Aggregate gross proceeds | $ 15,000 | |||||
Preferred Shares | 82,418 | |||||
Series B3 Redeemable Convertible Preferred Stock | Common Stock Warrants | ||||||
Temporary Equity | ||||||
Warrant to purchase stock | 6,593,440 | |||||
Warrant exercised price (per share) | $ 1.82 | |||||
Series B3 Redeemable Convertible Preferred Stock | Preferred Stock Warrant | ||||||
Temporary Equity | ||||||
Warrant to purchase stock | 65,934 | |||||
Warrant exercised price (per share) | $ 182 | |||||
Series B4 Redeemable Convertible Preferred Stock | ||||||
Temporary Equity | ||||||
Aggregate gross proceeds | $ 15,000 | |||||
Preferred Shares | 82,418 | |||||
Expiration period | 21 months | |||||
Series B4 Redeemable Convertible Preferred Stock | Common Stock Warrants | ||||||
Temporary Equity | ||||||
Warrant to purchase stock | 6,593,440 | |||||
Warrant exercised price (per share) | $ 1.82 | |||||
Series B4 Redeemable Convertible Preferred Stock | Preferred Stock Warrant | ||||||
Temporary Equity | ||||||
Warrant to purchase stock | 65,934 | |||||
Warrant exercised price (per share) | $ 182 |
Stockholders' Equity (Deficit_2
Stockholders' Equity (Deficit) - Preferred Stock (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Series A Preferred Stock [Member] | ||
Class of Stock | ||
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, par value | $ 0.01 | $ 0.01 |
Preferred stock, shares designated | 1,500,000 | 1,500,000 |
Annual percentage of dividend of preferred stock | 1.00% | |
Preferred stock, shares outstanding | 655 | 655 |
Series A preferred stock liquidation preference per share | $ 1 | |
Series A Preferred stock conversion price per share | $ 272 | |
Preferred stock, shares issued | 1,000 | 1,000 |
Series B1 Redeemable Convertible Preferred Stock | ||
Class of Stock | ||
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, par value | $ 0.01 | $ 0.01 |
Preferred stock, shares designated | 277,921 | 278,000 |
Preferred stock, shares outstanding | 0 | 24,000 |
Preferred stock, shares issued | 0 | 24,000 |
Series B2 Redeemable Convertible Preferred Stock | ||
Class of Stock | ||
Preferred stock, shares designated | 98,685 | |
Series B3 Redeemable Convertible Preferred Stock | ||
Class of Stock | ||
Preferred stock, shares designated | 82,814 | |
Series B4 Redeemable Convertible Preferred Stock | ||
Class of Stock | ||
Preferred stock, shares designated | 82,814 | |
Series B2 Preferred Stock | ||
Class of Stock | ||
Preferred stock, shares outstanding | 0 | 23,684 |
Stockholders' Equity (Deficit_3
Stockholders' Equity (Deficit) - Common Stock (Details) - USD ($) $ / shares in Units, $ in Thousands | Mar. 31, 2022 | Jul. 13, 2020 | Apr. 07, 2020 | Dec. 23, 2019 | Mar. 04, 2019 | May 05, 1998 | Nov. 30, 2018 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2021 | Mar. 04, 2022 |
Class of Stock | ||||||||||||
Common stock, shares reserved for future issuance | 23,918,172 | 23,918,172 | 14,906,278 | |||||||||
Par value (per share) | $ 0.001 | $ 0.001 | $ 0.001 | |||||||||
Proceeds from issuance | $ 3,900 | $ 10,072 | ||||||||||
Warrant exercised price (per share) | $ 2.04 | $ 1.28 | $ 2.04 | |||||||||
Directors [Member] | ||||||||||||
Class of Stock | ||||||||||||
Ownership percentage | 4.00% | 4.00% | ||||||||||
"At-The-Market" Equity Program | ||||||||||||
Class of Stock | ||||||||||||
Maximum value of shares that are permitted to be sold, subject to certain limitations | $ 19,500 | |||||||||||
Stock issued (in shares) | 5,117,357 | 3,608,713 | ||||||||||
Percentage of fixed commission expense of gross proceeds of shares sold in ATM agreement | 3.00% | |||||||||||
Net proceeds from offering of common stock | $ 15,300 | $ 12,300 | ||||||||||
Lincoln Park Capital Fund, LLC ("Investor") | ||||||||||||
Class of Stock | ||||||||||||
Value of shares which may be sold | $ 35,000 | |||||||||||
Duration over which common stock purchase agreement may be sold | 36 months | |||||||||||
Stock issued (in shares) | 269,749 | 800,000 | 750,000 | |||||||||
Stock issued (per share) | $ 2.84 | |||||||||||
Net proceeds from offering of common stock | $ 4,200 | $ 1,700 | ||||||||||
Common Stock [Member] | ||||||||||||
Class of Stock | ||||||||||||
Stock issued (in shares) | 149,960 | 5,918,000 | 8,218,000 | 2,068,000 | ||||||||
Sale price of common shares subject to the liquidation put | $ 128 | |||||||||||
Minimum closing sales price of common stock to issue termination notice to put holders | $ 256 | |||||||||||
Price exceeds on number of days | 20 days | |||||||||||
Liquidation put shares no longer held by original holders | 49,993 | |||||||||||
Shares held by put holders | 4,472 | |||||||||||
Put Rights outstanding | 0 | |||||||||||
Remaining shares of common stock subject to the liquidation put | 95,494 | |||||||||||
Common Stock [Member] | "At-The-Market" Equity Program | ||||||||||||
Class of Stock | ||||||||||||
Net proceeds from offering of common stock | $ 50,000 | |||||||||||
April 2020 Private Placement | ||||||||||||
Class of Stock | ||||||||||||
Stock issued (in shares) | 3,039,514 | |||||||||||
Shares of common stock that may be purchased upon exercise of warrants | 3,039,514 | |||||||||||
Warrant exercised price (per share) | $ 2.28 | |||||||||||
Gross proceeds from sale of common stock and warrants excluding the proceeds from exercise of the warrants, if any | $ 5,000 | |||||||||||
Combined purchase price (per share) | $ 1.645 | |||||||||||
Stock price underlying warrants (per share) | $ 0.125 | |||||||||||
April 2020 Private Placement Second Closing | ||||||||||||
Class of Stock | ||||||||||||
Stock issued (in shares) | 2,747,252 | |||||||||||
Ownership percentage | 19.99% | |||||||||||
Shares of common stock that may be purchased upon exercise of warrants | 1,373,626 | |||||||||||
Warrant exercised price (per share) | $ 2.71 | |||||||||||
Gross proceeds from sale of common stock and warrants excluding the proceeds from exercise of the warrants, if any | $ 5,000 | |||||||||||
Stock price (in dollars per share) | $ 0.01 | |||||||||||
April 2020 Private Placement and April 2020 Private Placement Second Closing in Aggregate | ||||||||||||
Class of Stock | ||||||||||||
Net proceeds from offering of common stock | $ 9,800 | |||||||||||
July 2020 Private Placement Second Closing | ||||||||||||
Class of Stock | ||||||||||||
Proceeds from issuance | $ 5,100 | |||||||||||
July 2020 Private Placement Second Closing | Pre-funded Warrants | ||||||||||||
Class of Stock | ||||||||||||
Shares of common stock that may be purchased upon exercise of warrants | 784,615 | |||||||||||
Stock price (in dollars per share) | $ 0.01 | |||||||||||
July 2020 Private Placement Second Closing | Warrants | ||||||||||||
Class of Stock | ||||||||||||
Shares of common stock that may be purchased upon exercise of warrants | 274,615 | |||||||||||
Stock price (in dollars per share) | $ 9.75 |
Stockholders' Equity (Deficit_4
Stockholders' Equity (Deficit) - Reverse Stock Split (Details) - $ / shares | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Stockholders' Equity (Deficit) | |||
Common stock, shares authorized | 140,000,000 | 140,000,000 | 140,000,000 |
Common stock, par value | $ 0.001 | $ 0.001 |
Stockholders' Equity (Deficit_5
Stockholders' Equity (Deficit) - Common Stock Warrants (Details) - $ / shares | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Class of Warrant or Right | |||
Number of Shares | 8,732,230 | 16,967,828 | |
Weighted-Average Exercise Price | $ 2.04 | $ 1.28 | |
Warrants | |||
Class of Warrant or Right | |||
Weighted-Average Exercise Price | $ 1.52 | ||
Preferred stock | |||
Class of Warrant or Right | |||
Weighted-Average Exercise Price | $ 152 | ||
Liability Classified Warrants | |||
Class of Warrant or Right | |||
Number of Shares | 2,368,400 | ||
December 2019 Series B1 warrants | |||
Class of Warrant or Right | |||
Number of Shares | 2,368,400 | ||
Weighted-Average Exercise Price | $ 1.52 | $ 1.52 | |
Equity Classified Warrants | |||
Class of Warrant or Right | |||
Number of Shares | 8,732,230 | 14,599,428 | |
May 2013 Warrants | |||
Class of Warrant or Right | |||
Number of Shares | 15,437 | 1,949,754 | |
Weighted-Average Exercise Price | $ 0.08 | $ 0.08 | |
September 2013 Warrants | |||
Class of Warrant or Right | |||
Number of Shares | 4,096 | 514,756 | |
Weighted-Average Exercise Price | $ 0.08 | $ 0.08 | |
February 2014 Warrants | |||
Class of Warrant or Right | |||
Number of Shares | 2,171 | 266,006 | |
Weighted-Average Exercise Price | $ 0.08 | $ 0.08 | |
April 2020 Private Placement first closing warrants | |||
Class of Warrant or Right | |||
Number of Shares | 3,039,514 | 3,039,514 | |
Weighted-Average Exercise Price | $ 2.28 | ||
April 2020 Private Placement second closing warrants | |||
Class of Warrant or Right | |||
Number of Shares | 1,373,626 | 1,373,626 | |
Weighted-Average Exercise Price | $ 2.71 | ||
April 2020 Private Placement second closing warrants | |||
Class of Warrant or Right | |||
Number of Shares | 1,143,428 | 2,677,311 | |
Weighted-Average Exercise Price | $ 0.01 | ||
July 2020 Private Placement first closing warrants | |||
Class of Warrant or Right | |||
Number of Shares | 389,731 | 2,014,234 | |
Weighted-Average Exercise Price | $ 0.01 | ||
July 2020 Private Placement first closing warrants | |||
Class of Warrant or Right | |||
Number of Shares | 2,764,227 | 2,764,227 | |
Weighted-Average Exercise Price | $ 2.58 |
Stockholders' Equity (Deficit_6
Stockholders' Equity (Deficit) - Common Stock Warrant Activity (Details) | 12 Months Ended |
Dec. 31, 2021$ / sharesshares | |
Class of Warrant or Right | |
Outstanding at December 31, 2020 | shares | 16,967,828 |
Exercised | shares | (5,867,198) |
Outstanding at December 31, 2021 | shares | 8,732,230 |
Warrant exercise price at December 31,2020 | $ / shares | $ 1.28 |
Exercised | $ / shares | 0.04 |
Warrant exercise price at December 31,2021 | $ / shares | $ 2.04 |
Class of Warrant Two [Member] | |
Class of Warrant or Right | |
Expired | shares | (2,368,400) |
Warrant exercise price per share, expired | $ / shares | 1.52 |
Alliance Revenue (Details)
Alliance Revenue (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Alliance Revenue | |
Alliance revenue | $ 1,448 |
Out-license arrangement | |
Alliance Revenue | |
Alliance revenue | $ 1,400 |
Collaboration and License Agr_2
Collaboration and License Agreements (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | |||
Feb. 28, 2021 | Apr. 30, 2019 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions | |||||
Alliance revenue | $ 1,448 | ||||
Revenue, Product and Service [Extensible List] | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember | ||
Research and development | $ 16,375 | $ 24,772 | $ 34,853 | ||
Option and License Agreement with Licensee | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions | |||||
Transaction price | 1,400 | ||||
Performance obligation | $ 0 | ||||
Percentage of shares acquired | 10.00% | 10.00% | |||
Option and License Agreement with Licensee | Other Assets | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions | |||||
Value of securities without a readily determinable fair value | $ 100 | ||||
Scriptr Global, Inc. | Research and Development Plans and Designation of Development Candidates [Member] | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions | |||||
Research and development | $ 2,100 | ||||
Scriptr Global, Inc. | Maximum [Member] | Research and Development Plans and Designation of Development Candidates [Member] | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions | |||||
Deferred revenue recognition period | 270 days | ||||
IMO-9200 License | Option and License Agreement with Licensee | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions | |||||
Upfront payment received under collaboration agreement | $ 1,400 |
Stock-Based Compensation - Equi
Stock-Based Compensation - Equity Incentive Plans (Details) - shares | Jul. 26, 2013 | Dec. 31, 2021 | Mar. 04, 2022 | Dec. 31, 2020 |
Class of Stock | ||||
Common stock, shares reserved for future issuance | 23,918,172 | 14,906,278 | ||
Common stock options outstanding | 5,202,006 | 4,614,323 | ||
Options outstanding under earlier plans | 155,968 | |||
Grant of inducement stock option | 325,000 | |||
2013 Stock Incentive Plan [Member] | ||||
Class of Stock | ||||
Common shares available for grant | 5,653,057 | 199,873 | ||
Maximum number of additional common shares | 868,372 | |||
Common stock options outstanding | 4,721,038 | |||
Restricted stock units outstanding | 575,703 |
Stock-Based Compensation - Empl
Stock-Based Compensation - Employee Stock Purchase Plans (Details) - USD ($) | 12 Months Ended | |||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Jun. 07, 2017 | |
Class of Stock | ||||
Proceeds from employee stock purchases | $ 59,000 | $ 113,000 | $ 121,000 | |
Percentage of share-based compensation expense | 15.00% | |||
Weighted average grant date fair value of options granted during the period (per share) | $ 1.54 | $ 1.25 | $ 1.64 | |
2017 Employee Stock Purchase Plan | ||||
Class of Stock | ||||
Maximum percentage of total combined voting power or value of the stock of the Company after the grant | 5.00% | |||
Common shares available for grant | 196,225 | |||
Common stock share issued | 49,117 | 75,999 | 60,953 | |
Employee Stock Purchase Plan [Member] | ||||
Class of Stock | ||||
Minimum percentage in payroll of deduction base salary to acquire shares of common stock | 1.00% | |||
Maximum percentage in payroll of deduction base salary to acquire shares of common stock | 10.00% | |||
Percentage of fair market value of common stock for the ESPP option price | 85.00% | |||
Annual maximum a participant may purchase under the employee stock purchase plan | $ 25,000 | |||
Defined Contribution Plan, Cost | $ 100,000 | $ 100,000 | $ 100,000 | |
Maximum [Member] | 2017 Employee Stock Purchase Plan | ||||
Class of Stock | ||||
Common stock shares authorized for issuance under stock purchase plan | 412,500 | |||
Maximum [Member] | Employee Stock Purchase Plan [Member] | ||||
Class of Stock | ||||
Subsequent offering period as established by the compensation committee | 12 months |
Stock-Based Compensation - Acco
Stock-Based Compensation - Accounting for Stock-based Compensation (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award | |||
Stock-based compensation | $ 2,537 | $ 3,641 | $ 3,845 |
Research and development | |||
Share-based Compensation Arrangement by Share-based Payment Award | |||
Stock-based compensation | 574 | 761 | 1,348 |
Research and development | Employee Stock Purchase Plan [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award | |||
Stock-based compensation | 28 | 88 | 36 |
Research and development | Equity Incentive Plans | |||
Share-based Compensation Arrangement by Share-based Payment Award | |||
Stock-based compensation | 546 | 673 | 1,312 |
General and administrative | |||
Share-based Compensation Arrangement by Share-based Payment Award | |||
Stock-based compensation | 1,963 | 2,880 | 2,497 |
General and administrative | Employee Stock Purchase Plan [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award | |||
Stock-based compensation | 3 | 9 | 20 |
General and administrative | Equity Incentive Plans | |||
Share-based Compensation Arrangement by Share-based Payment Award | |||
Stock-based compensation | $ 1,960 | $ 2,871 | $ 2,477 |
Stock-Based Compensation - Assu
Stock-Based Compensation - Assumptions Used in Determining Fair Value of Stock Options (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Stock-Based Compensation | |||
Options to purchase common stock granted to employees and directors | 1,356,700 | 1,215,382 | 1,279,016 |
Average risk free interest rate | 0.40% | 1.00% | 2.10% |
Dividend rate | 0.00% | ||
Expected lives (years) | 3 years 7 months 6 days | 3 years 10 months 24 days | 3 years 8 months 12 days |
Expected volatility | 94.00% | 84.00% | 84.00% |
Weighted average exercise price of options granted during the period (per share) | $ 2.68 | $ 2.08 | $ 2.75 |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Mar. 31, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Stock-Based Compensation | ||||
Options, Outstanding, Beginning Balance | 4,614,323 | |||
Granted | 1,356,700 | |||
Exercised | (22,500) | |||
Forfeited | (261,426) | |||
Expired | (485,091) | |||
Options, Outstanding, Ending Balance | 5,202,006 | 4,614,323 | ||
Exercisable, Ending Balance | 4,096,875 | |||
Weighted Average Exercise Price, Beginning Balance | $ 9.78 | |||
Granted, Weighted Average Exercise Price | 2.68 | $ 2.08 | $ 2.75 | |
Exercised, Weighted Average Exercise Price | 2.11 | |||
Forfeited, Weighted Average Exercise Price | 4.44 | |||
Expired, Weighted Average Exercise Price | 11.52 | |||
Weighted Average Exercise Price, Ending Balance | 8.06 | $ 9.78 | ||
Exercisable, Weighted Average Exercise Price | $ 9.62 | |||
Outstanding, Ending balance, Weighted Average Remaining Contractual Term | 5 years 10 months 24 days | 6 years 9 months 18 days | ||
Exercisable Ending Balance, Weighted Average Remaining Contractual Term | 5 years 1 month 6 days | |||
Outstanding, Intrinsic Value, Ending Balance | $ 2,949 | |||
Number of shares vested | 1,535,578 | |||
Unrecognized compensation cost related to nonvested stock-based compensation | $ 1,200 | |||
Weighted average remaining period over which unrecognized compensation expense will be recognized | 2 years 1 month 6 days |
Stock-Based Compensation - Rest
Stock-Based Compensation - Restricted Stock Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | |||||
Mar. 31, 2021 | Dec. 31, 2020 | Jul. 31, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Jul. 26, 2013 | |
Restricted Stock Activity, Weighted-Average Grant Date Fair Value | |||||||
Unrecognized compensation expense | $ 1,200 | ||||||
Weighted average remaining period over which unrecognized compensation expense will be recognized | 2 years 1 month 6 days | ||||||
Share-based compensation | $ 2,537 | $ 3,641 | $ 3,845 | ||||
2013 Stock Incentive Plan [Member] | |||||||
Restricted Stock Activity, Number of Shares | |||||||
Nonvested shares, Ending Balance | 575,703 | ||||||
Restricted Stock Activity, Weighted-Average Grant Date Fair Value | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 199,873 | 5,653,057 | |||||
Restricted stock units | |||||||
Restricted Stock Activity, Number of Shares | |||||||
Nonvested shares, Beginning Balance | 354,003 | ||||||
Cancelled | (48,563) | ||||||
Vested | (236,765) | ||||||
Nonvested shares, Ending Balance | 354,003 | 68,675 | 354,003 | ||||
Restricted Stock Activity, Weighted-Average Grant Date Fair Value | |||||||
Nonvested shares, Weighted Average Grant Date Fair Value, Beginning Balance | $ 2.27 | ||||||
Cancelled, Weighted-Average Grant Date Fair Value | 2.31 | ||||||
Vested, Weighted-Average Grant Date Fair Value | 2.25 | ||||||
Nonvested shares, Weighted Average Grant Date Fair Value, Ending Balance | $ 2.27 | $ 2.30 | $ 2.27 | ||||
Accelerated vesting, number of shares | 137,872 | ||||||
Recognized compensation expense | $ 300 | ||||||
Unrecognized compensation expense | $ 100 | ||||||
Weighted average remaining period over which unrecognized compensation expense will be recognized | 1 year 7 months 6 days | ||||||
Restricted stock units | 2013 Stock Incentive Plan [Member] | |||||||
Restricted Stock Activity, Number of Shares | |||||||
Granted | 128,170 | ||||||
Market/Performance-based Awards | |||||||
Restricted Stock Activity, Number of Shares | |||||||
Nonvested shares, Beginning Balance | 549,318 | ||||||
Cancelled | (42,290) | ||||||
Nonvested shares, Ending Balance | 549,318 | 507,028 | 549,318 | ||||
Restricted Stock Activity, Weighted-Average Grant Date Fair Value | |||||||
Nonvested shares, Weighted Average Grant Date Fair Value, Beginning Balance | $ 1.54 | ||||||
Cancelled, Weighted-Average Grant Date Fair Value | 1.54 | ||||||
Nonvested shares, Weighted Average Grant Date Fair Value, Ending Balance | $ 1.54 | $ 1.54 | $ 1.54 | ||||
Weighted average remaining period over which unrecognized compensation expense will be recognized | 10 months 24 days | ||||||
Requisite service period (in years) | 2 years 4 months 9 days | ||||||
Share-based compensation | $ 300 | ||||||
Unrecognized compensation expense related to the restricted stock units | 300 | ||||||
Additional compensation expense as a result of meeting certain achievements | $ 300 |
Commitments and Contingencies -
Commitments and Contingencies - Rent Expense and Lease Information (Details) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021USD ($)ft² | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | |
Property, Plant and Equipment [Line Items] | |||
Rent expense, including real estate taxes | $ 0.3 | $ 0.4 | |
Rent expense, including real estate taxes | $ 0.3 | ||
Vendor financing arrangement, outstanding balance | $ 0 | ||
Vendor Financing Arrangement | |||
Property, Plant and Equipment [Line Items] | |||
Vendor financing arrangement, outstanding balance | $ 0.4 | ||
Exton Facility [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Leased office space | ft² | 11,000 |
Commitments and Contingencies_2
Commitments and Contingencies - Future Minimum Commitments Under Lease Agreements (Details) $ in Thousands | Dec. 31, 2021USD ($) |
Commitments and Contingencies | |
2022 | $ 249 |
2023 | 250 |
2024 | 240 |
2025 | 101 |
Total future minimum lease commitments | $ 840 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Income Taxes | |||
Unrecognized tax benefits from uncertain tax | $ 0 | $ 0 | $ 0 |
Period over which material changes in unrecognized tax positions are not expected | 12 months | ||
Federal [Member] | |||
Income Taxes | |||
Cumulative net operating loss carryforwards | $ 327,500 | ||
Percentage of taxable income that can be used to offset future taxable periods as a result of the TCJA | 80.00% | ||
Unlimited carryforward | $ 130,100 | ||
Tax credit carryforwards | 26,700 | ||
State [Member] | |||
Income Taxes | |||
Cumulative net operating loss carryforwards | 322,000 | ||
Tax credit carryforwards | $ 1,900 | ||
State [Member] | Massachusetts | |||
Income Taxes | |||
Carryforward term | 20 years | ||
Potential amount that may expire in a future period | $ 23,400 | ||
State [Member] | Pennsylvania | |||
Income Taxes | |||
Carryforward term | 20 years |
Income Taxes - Components of th
Income Taxes - Components of the Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Income Taxes | ||
Operating loss carryforwards | $ 90,550 | $ 90,895 |
Tax credit carryforwards | 28,226 | 26,550 |
Stock-based compensation | 6,902 | 6,820 |
Capitalized research and development | 7,818 | |
Lease liabilities | 220 | 276 |
Other | 70 | 162 |
Total deferred tax assets | 133,786 | 124,703 |
Right-of-use asset | (213) | (270) |
Valuation allowance | $ (133,573) | $ (124,433) |
Income Taxes - Difference Betwe
Income Taxes - Difference Between U.S. Federal Corporate Tax Rate and Company's Effective Tax Rate (Details) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Income Taxes | |||
Expected federal income tax rate | (21.00%) | (21.00%) | (21.00%) |
Change in valuation allowance | (9.30%) | 10.60% | 26.20% |
Federal and state credits | 1.70% | (3.10%) | (8.10%) |
State income taxes, net of federal benefit | 2.10% | (1.90%) | (4.70%) |
Warrant and future tranche right revaluation loss | 26.90% | 14.20% | 4.30% |
Stock-based compensation | 0.20% | 0.50% | |
Other | (0.40%) | 1.00% | 2.80% |
Effective tax rate | 0.00% | 0.00% | 0.00% |
Employee Benefit Plan (Details)
Employee Benefit Plan (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Employee Benefit Plan | |||
Maximum employer match as a percentage of base pay | 5.00% | ||
Percentage the employer matches of employee contributions | 100.00% | ||
Portion of the employee's base salary that the Company matches | 5.00% | ||
Employer matching contributions to the plan | $ 0.3 | $ 0.3 | $ 0.3 |
Related Party Transactions - Ov
Related Party Transactions - Overview of Related Parties (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||
Apr. 30, 2021 | Mar. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Related Party Transactions | |||||||
Exercise price of warrants | $ 1.28 | $ 1.28 | $ 2.04 | $ 1.28 | |||
Number of Shares | 16,967,828 | 16,967,828 | 8,732,230 | 16,967,828 | |||
Common stock issued in lieu of board fees | 105,691 | 145,392 | 53,985 | ||||
Restricted stock units | 2013 Stock Incentive Plan [Member] | |||||||
Related Party Transactions | |||||||
Award granted | 128,170 | ||||||
Directors [Member] | |||||||
Related Party Transactions | |||||||
Ownership percentage | 4.00% | ||||||
Aggregate common shares | 2,047,180 | ||||||
Maximum [Member] | |||||||
Related Party Transactions | |||||||
Proceeds from issuance of common stock in lieu of director board and committee fees | $ 0.1 | $ 0.3 | $ 0.1 | ||||
Series B1 Redeemable Convertible Preferred Stock | |||||||
Related Party Transactions | |||||||
Conversion of preferred stock to common, shares | 23,684 | ||||||
Baker Bros. Advisors LP [Member] | |||||||
Related Party Transactions | |||||||
Issuance of common stock upon exercise of warrants (in shares) | 2,708,812 | ||||||
Exercise price of warrants | $ 0.08 | ||||||
Proceeds from exercise of warrants | $ 0.2 | ||||||
Maximum beneficial ownership percentage holding, after convertible securities converted | 4.99% | ||||||
Prior notice period (in days) | 61 days | ||||||
Baker Bros. Advisors LP [Member] | Maximum [Member] | |||||||
Related Party Transactions | |||||||
Maximum beneficial ownership percentage holding, after convertible securities converted | 19.99% | ||||||
Baker Bros. Advisors LP [Member] | Series B1 Redeemable Convertible Preferred Stock | |||||||
Related Party Transactions | |||||||
Aggregate common shares | 9,534 | ||||||
Conversion of preferred stock to common, shares | 14,150 | ||||||
Baker Bros. Advisors LP [Member] | Common stock | |||||||
Related Party Transactions | |||||||
Shares issued on exercise of warrants during the period | 953,400 | 1,415,000 | |||||
Pillar Investment Entities | |||||||
Related Party Transactions | |||||||
Ownership percentage | 19.99% | ||||||
Issuance of common stock upon exercise of warrants (in shares) | 3,158,386 | ||||||
Exercise price of warrants | $ 0.01 | ||||||
Proceeds from exercise of warrants | $ 0.1 | ||||||
Cashless shares | 19,052 | ||||||
Pillar Investment Entities | Pre-funded Warrants | |||||||
Related Party Transactions | |||||||
Exercise price of warrants | $ 0.01 | ||||||
Number of Shares | 1,533,159 | ||||||
Pillar Investment Entities | Warrant, Tranche One | |||||||
Related Party Transactions | |||||||
Exercise price of warrants | $ 2.28 | ||||||
Number of Shares | 3,039,514 | ||||||
Pillar Investment Entities | Warrant, Tranche Two | |||||||
Related Party Transactions | |||||||
Exercise price of warrants | $ 2.58 | ||||||
Number of Shares | 2,764,227 | ||||||
Pillar Investment Entities | Warrant, Tranche Three | |||||||
Related Party Transactions | |||||||
Exercise price of warrants | $ 2.71 | ||||||
Number of Shares | 1,373,626 | ||||||
Chief Executive Officer | 2013 Stock Incentive Plan [Member] | |||||||
Related Party Transactions | |||||||
Award granted | 128,170 | 0 | |||||
Proceeds from issuance of restricted stock in lieu of salary | $ 0.6 |
Net Income (Loss) per Common _3
Net Income (Loss) per Common Share Applicable to Common Stockholders -Computation of basic and diluted net income per common share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Net income (loss) applicable to common stockholders - Basic: | |||
Net income (loss) | $ 98,091 | $ (112,662) | $ (56,515) |
Less: Deemed dividend on preferred stock | (28,043) | ||
Less: Undistributed earnings to preferred stockholders | (1,150) | ||
Net income (loss) applicable to common stockholders | 96,941 | (112,662) | (84,558) |
Numerator for basic net income (loss) applicable to common stockholders | $ 96,941 | $ (112,662) | $ (84,558) |
Denominator for basic net income (loss) applicable to common stockholders | 49,203 | 33,821 | 28,545 |
Net income (loss) income applicable to common stockholders - basic | $ 1.97 | $ (3.33) | $ (2.96) |
Net loss applicable to common stockholders - Diluted: | |||
Net income (loss) | $ 96,941 | $ (112,662) | $ (84,558) |
Less: Warrant revaluation gain applicable to dilutive liability-classified warrants | (6,983) | ||
Less: Future tranche right revaluation gain applicable to dilutive liability-classified future tranche rights | (118,803) | ||
Numerator for diluted net income (loss) applicable to common stockholders | $ (28,845) | $ (112,662) | $ (84,558) |
Denominator for basic net income (loss) applicable to common stockholders | 49,203 | 33,821 | 28,545 |
Plus: Incremental shares underlying "in the money" warrants outstanding | 93 | ||
Plus: Incremental shares underlying "in the money" liability-classified future tranche rights outstanding | 831 | ||
Denominator for diluted net income (loss) applicable to common stockholders | 50,127 | 33,821 | 28,545 |
Net income (loss) applicable to common stockholders - diluted | $ (0.58) | $ (3.33) | $ (2.96) |
Net Income (Loss) per Common _4
Net Income (Loss) per Common Share Applicable to Common Stockholders - Antidilutive securities (Details) - shares shares in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Antidilutive securities | |||
Total antidilutive securities | 14,510 | 75,321 | 61,289 |
Stock options | |||
Antidilutive securities | |||
Total antidilutive securities | 5,202 | 4,614 | 4,220 |
Restricted stock units | |||
Antidilutive securities | |||
Total antidilutive securities | 576 | 903 | 194 |
Common Stock Warrants | |||
Antidilutive securities | |||
Total antidilutive securities | 8,732 | 16,968 | 5,099 |
Convertible preferred stock | |||
Antidilutive securities | |||
Total antidilutive securities | 2,369 | 2,369 | |
Future tranche right liability | |||
Antidilutive securities | |||
Total antidilutive securities | 50,467 | 49,407 |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Subsequent Events | |||
Sale of common stock, net of issuance costs | $ 19,515 | $ 28,646 | $ 5,298 |
"At-The-Market" Equity Program | |||
Subsequent Events | |||
Stock issued (in shares) | 5,117,357 | 3,608,713 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - New Accounting Pronouncements (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
New Accounting Pronouncements - Recently Issued | ||
Operating lease right-of-use assets | $ 734 | $ 930 |