Cover
Cover - shares | 6 Months Ended | |
Jun. 30, 2023 | Aug. 04, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2023 | |
Document Transition Report | false | |
Entity File Number | 001-35670 | |
Entity Registrant Name | Regulus Therapeutics Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 26-4738379 | |
Entity Address, Address Line One | 4224 Campus Point Court, Suite 210 | |
Entity Address, City or Town | San Diego | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 92121 | |
City Area Code | 858 | |
Local Phone Number | 202-6300 | |
Title of 12(b) Security | Common Stock, par value $0.001 per share | |
Trading Symbol | RGLS | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 19,484,461 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q2 | |
Entity Central Index Key | 0001505512 | |
Current Fiscal Year End Date | --12-31 |
CONDENSED BALANCE SHEETS
CONDENSED BALANCE SHEETS - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 37,263 | $ 24,228 |
Short-term investments | 0 | 14,932 |
Restricted cash | 62 | 62 |
Contract and other receivables | 3 | 0 |
Prepaid materials, net | 3,010 | 3,010 |
Prepaid expenses and other current assets | 1,025 | 1,847 |
Total current assets | 41,363 | 44,079 |
Property and equipment, net | 482 | 536 |
Intangibles, net | 39 | 62 |
Right of use asset | 1,763 | 2,039 |
Total assets | 43,647 | 46,716 |
Current liabilities: | ||
Accounts payable | 362 | 175 |
Accrued liabilities | 623 | 961 |
Accrued research and development expenses | 756 | 1,252 |
Accrued compensation | 1,530 | 2,205 |
Current portion of term loan, less debt issuance costs | 2,922 | 4,511 |
Other current liabilities | 2,036 | 2,553 |
Total current liabilities | 8,229 | 11,657 |
Lease liability, less current portion | 1,421 | 1,768 |
Total liabilities | 9,650 | 13,425 |
Commitments and Contingencies | ||
Stockholders’ equity: | ||
Common stock, $0.001 par value; 300,000,000 shares authorized at June 30, 2023 and December 31, 2022; 19,484,461 and 16,840,261 shares issued and outstanding at June 30, 2023 (unaudited) and December 31, 2022, respectively | 19 | 17 |
Additional paid-in capital | 531,301 | 516,457 |
Accumulated other comprehensive loss | 0 | (12) |
Accumulated deficit | (497,328) | (483,176) |
Total stockholders’ equity | 33,997 | 33,291 |
Total liabilities and stockholders’ equity | 43,647 | 46,716 |
Class A-1 Convertible Preferred Stock | ||
Stockholders’ equity: | ||
Preferred stock | 0 | 0 |
Class A-2 Convertible Preferred Stock | ||
Stockholders’ equity: | ||
Preferred stock | 1 | 1 |
Class A-3 Convertible Preferred Stock | ||
Stockholders’ equity: | ||
Preferred stock | 0 | 0 |
Class A-4 Convertible Preferred Stock | ||
Stockholders’ equity: | ||
Preferred stock | 4 | 4 |
Class A-5 Convertible Preferred Stock | ||
Stockholders’ equity: | ||
Preferred stock | $ 0 | $ 0 |
CONDENSED BALANCE SHEETS (Paren
CONDENSED BALANCE SHEETS (Parenthetical) - $ / shares | Jun. 30, 2023 | Dec. 31, 2022 |
Common stock par value (in usd per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 300,000,000 | 300,000,000 |
Common stock, shares issued (in shares) | 19,484,461 | 16,840,261 |
Common stock, shares outstanding (in shares) | 19,484,461 | 16,840,261 |
Class A-1 Convertible Preferred Stock | ||
Preferred stock, par value (in usd per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 256,700 | 256,700 |
Preferred stock, shares issued (in shares) | 256,700 | 256,700 |
Preferred stock, shares outstanding (in shares) | 256,700 | 256,700 |
Class A-2 Convertible Preferred Stock | ||
Preferred stock, par value (in usd per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 1,330,832 | 1,330,832 |
Preferred stock, shares issued (in shares) | 1,330,832 | 1,330,832 |
Preferred stock, shares outstanding (in shares) | 1,330,832 | 1,330,832 |
Class A-3 Convertible Preferred Stock | ||
Preferred stock, par value (in usd per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 258,707 | 258,707 |
Preferred stock, shares issued (in shares) | 258,707 | 258,707 |
Preferred stock, shares outstanding (in shares) | 258,707 | 258,707 |
Class A-4 Convertible Preferred Stock | ||
Preferred stock, par value (in usd per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 3,725,720 | 3,725,720 |
Preferred stock, shares issued (in shares) | 3,725,720 | 3,725,720 |
Preferred stock, shares outstanding (in shares) | 3,725,720 | 3,725,720 |
Class A-5 Convertible Preferred Stock | ||
Preferred stock, par value (in usd per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 140,827 | 140,827 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
CONDENSED STATEMENTS OF OPERATI
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Operating expenses: | ||||
Research and development | $ 4,976 | $ 4,708 | $ 9,901 | $ 8,387 |
General and administrative | 2,339 | 2,467 | 4,783 | 5,357 |
Total operating expenses | 7,315 | 7,175 | 14,684 | 13,744 |
Loss from operations | (7,315) | (7,175) | (14,684) | (13,744) |
Other income (expense): | ||||
Interest and other income | 471 | 79 | 886 | 85 |
Interest and other expense | (168) | (162) | (353) | (317) |
Loss before income taxes | (7,012) | (7,258) | (14,151) | (13,976) |
Income tax expense | (1) | 0 | (1) | (1) |
Net loss and comprehensive loss | (7,013) | (7,258) | (14,152) | (13,977) |
Other comprehensive loss: | ||||
Unrealized loss on short-term investments, net | 0 | (36) | 0 | (36) |
Comprehensive loss | $ (7,013) | $ (7,294) | $ (14,152) | $ (14,013) |
Net loss per share, basic (in usd per share) | $ (0.37) | $ (0.50) | $ (0.79) | $ (0.96) |
Net loss per share, diluted (in usd per share) | $ (0.37) | $ (0.50) | $ (0.79) | $ (0.96) |
Weighted average shares used to compute basic net loss per share (in shares) | 19,101,969 | 14,612,312 | 17,979,343 | 14,604,594 |
Weighted average shares used to compute diluted net loss per share (in shares) | 19,101,969 | 14,612,312 | 17,979,343 | 14,604,594 |
CONDENSED STATEMENTS OF CHANGES
CONDENSED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (DEFICIT) - USD ($) $ in Thousands | Total | Convertible preferred stock Convertible preferred stock | Common stock | Additional paid-in capital | Accumulated other comprehensive income (loss) | Accumulated deficit |
Beginning balance, preferred stock shares (in shares) at Dec. 31, 2021 | 5,571,959 | |||||
Beginning balance, common stock shares (in shares) at Dec. 31, 2021 | 14,597,118 | |||||
Beginning balance at Dec. 31, 2021 | $ 54,958 | $ 5 | $ 15 | $ 509,791 | $ 0 | $ (454,853) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Issuance of common stock under Employee Stock Purchase Plan (in shares) | 996 | |||||
Issuance of common stock under Employee Stock Purchase Plan | 2 | 2 | ||||
Stock-based compensation expense | 1,000 | 1,000 | ||||
Net loss | (6,719) | (6,719) | ||||
Ending balance, preferred stock shares (in shares) at Mar. 31, 2022 | 5,571,959 | |||||
Ending balance, common stock shares (in shares) at Mar. 31, 2022 | 14,598,114 | |||||
Ending balance at Mar. 31, 2022 | 49,241 | $ 5 | $ 15 | 510,793 | 0 | (461,572) |
Beginning balance, preferred stock shares (in shares) at Dec. 31, 2021 | 5,571,959 | |||||
Beginning balance, common stock shares (in shares) at Dec. 31, 2021 | 14,597,118 | |||||
Beginning balance at Dec. 31, 2021 | 54,958 | $ 5 | $ 15 | 509,791 | 0 | (454,853) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Net loss | (13,977) | |||||
Ending balance, preferred stock shares (in shares) at Jun. 30, 2022 | 5,571,959 | |||||
Ending balance, common stock shares (in shares) at Jun. 30, 2022 | 14,634,414 | |||||
Ending balance at Jun. 30, 2022 | 42,367 | $ 5 | $ 15 | 511,213 | (36) | (468,830) |
Beginning balance, preferred stock shares (in shares) at Mar. 31, 2022 | 5,571,959 | |||||
Beginning balance, common stock shares (in shares) at Mar. 31, 2022 | 14,598,114 | |||||
Beginning balance at Mar. 31, 2022 | 49,241 | $ 5 | $ 15 | 510,793 | 0 | (461,572) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Issuance of common stock upon vesting of restricted stock units (in shares) | 36,300 | |||||
Stock-based compensation expense | 420 | 420 | ||||
Gain (loss) on short term investments | (36) | (36) | ||||
Net loss | (7,258) | (7,258) | ||||
Ending balance, preferred stock shares (in shares) at Jun. 30, 2022 | 5,571,959 | |||||
Ending balance, common stock shares (in shares) at Jun. 30, 2022 | 14,634,414 | |||||
Ending balance at Jun. 30, 2022 | $ 42,367 | $ 5 | $ 15 | 511,213 | (36) | (468,830) |
Beginning balance, preferred stock shares (in shares) at Dec. 31, 2022 | 5,571,959 | |||||
Beginning balance, common stock shares (in shares) at Dec. 31, 2022 | 16,840,261 | 16,840,261 | ||||
Beginning balance at Dec. 31, 2022 | $ 33,291 | $ 5 | $ 17 | 516,457 | (12) | (483,176) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Issuance of common stock under Employee Stock Purchase Plan (in shares) | 19,472 | |||||
Issuance of common stock under Employee Stock Purchase Plan | 21 | 21 | ||||
Stock-based compensation expense | 410 | 410 | ||||
Gain (loss) on short term investments | 12 | 12 | ||||
Net loss | (7,139) | (7,139) | ||||
Ending balance, preferred stock shares (in shares) at Mar. 31, 2023 | 5,571,959 | |||||
Ending balance, common stock shares (in shares) at Mar. 31, 2023 | 16,859,733 | |||||
Ending balance at Mar. 31, 2023 | $ 26,595 | $ 5 | $ 17 | 516,888 | 0 | (490,315) |
Beginning balance, preferred stock shares (in shares) at Dec. 31, 2022 | 5,571,959 | |||||
Beginning balance, common stock shares (in shares) at Dec. 31, 2022 | 16,840,261 | 16,840,261 | ||||
Beginning balance at Dec. 31, 2022 | $ 33,291 | $ 5 | $ 17 | 516,457 | (12) | (483,176) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Net loss | $ (14,152) | |||||
Ending balance, preferred stock shares (in shares) at Jun. 30, 2023 | 5,712,786 | |||||
Ending balance, common stock shares (in shares) at Jun. 30, 2023 | 19,484,461 | 19,484,461 | ||||
Ending balance at Jun. 30, 2023 | $ 33,997 | $ 5 | $ 19 | 531,301 | 0 | (497,328) |
Beginning balance, preferred stock shares (in shares) at Mar. 31, 2023 | 5,571,959 | |||||
Beginning balance, common stock shares (in shares) at Mar. 31, 2023 | 16,859,733 | |||||
Beginning balance at Mar. 31, 2023 | 26,595 | $ 5 | $ 17 | 516,888 | 0 | (490,315) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Issuance of common stock and preferred stock from private placement, net of offering costs (in shares) | 140,827 | 2,615,536 | ||||
Issuance of common stock and preferred stock from private placement, net of offering costs | 14,003 | $ 2 | 14,001 | |||
Stock-based compensation expense | 382 | 382 | ||||
Issuance of common stock through ATM (in shares) | 9,192 | |||||
Issuance of common stock through ATM | 30 | 30 | ||||
Net loss | $ (7,013) | (7,013) | ||||
Ending balance, preferred stock shares (in shares) at Jun. 30, 2023 | 5,712,786 | |||||
Ending balance, common stock shares (in shares) at Jun. 30, 2023 | 19,484,461 | 19,484,461 | ||||
Ending balance at Jun. 30, 2023 | $ 33,997 | $ 5 | $ 19 | $ 531,301 | $ 0 | $ (497,328) |
CONDENSED STATEMENTS OF CASH FL
CONDENSED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | |
Operating activities | ||
Net loss | $ (14,152) | $ (13,977) |
Adjustments to reconcile net loss to net cash used in operating activities | ||
Depreciation and amortization expense | 95 | 57 |
Stock-based compensation | 792 | 1,420 |
Amortization of premiums and accretion of discounts on investments, net | (56) | (20) |
Other | 81 | 70 |
Change in operating assets and liabilities: | ||
Contracts and other receivables | (3) | 0 |
Prepaid expenses and other assets | 821 | 990 |
Accounts payable | 188 | 311 |
Accrued liabilities | (371) | (6) |
Accrued research and development expenses | (497) | (55) |
Accrued compensation | (676) | (623) |
Operating lease right-of-use assets and liabilities, net | (40) | (28) |
Other liabilities | (548) | (679) |
Net cash used in operating activities | (14,366) | (12,540) |
Investing activities | ||
Purchases of short-term investments | 0 | (12,431) |
Sales of short-term investments | 15,000 | 0 |
Purchases of property and equipment | (1) | (295) |
Net cash provided by (used in) investing activities | 14,999 | (12,726) |
Financing activities | ||
Proceeds from issuance of securities through private placement, net of issuance costs | 14,003 | 0 |
Proceeds from issuance of common stock, net | 51 | 2 |
Principal payments on term loan | (1,652) | 0 |
Net cash provided by financing activities | 12,402 | 2 |
Net increase (decrease) in cash and cash equivalents | 13,035 | (25,264) |
Cash and cash equivalents at beginning of period | 24,290 | 60,445 |
Cash and cash equivalents at end of period | 37,325 | 35,181 |
Reconciliation of cash, cash equivalents and restricted cash | ||
Cash and cash equivalents | 37,263 | 35,119 |
Restricted cash | 62 | 62 |
Total cash, cash equivalents and restricted cash | 37,325 | 35,181 |
Supplemental disclosure of cash flow information | ||
Interest paid | (276) | (226) |
Income taxes paid | (1) | (1) |
Supplemental disclosure of non-cash investing and financing activities | ||
Non-cash acquisition of property and equipment | $ 33 | $ 0 |
Basis of Presentation and Summa
Basis of Presentation and Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Summary of Significant Accounting Policies | Basis of Presentation and Summary of Significant Accounting Policies Basis of Presentation The accompanying unaudited condensed financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and the instructions to Form 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In management’s opinion, the accompanying financial statements reflect all adjustments, consisting of normal recurring adjustments, considered necessary for a fair presentation of the results for the interim periods presented. Interim financial results are not necessarily indicative of results anticipated for the full year. These unaudited condensed financial statements should be read in conjunction with the audited financial statements and footnotes included in our Annual Report on Form 10-K for the year ended December 31, 2022, from which the balance sheet information herein was derived. On June 24, 2022, we filed a Certificate of Amendment of Amended and Restated Certificate of Incorporation with the Secretary of State of the state of Delaware to effect a 1-for-10 reverse stock split of our issued and outstanding common stock. The primary purpose of the reverse stock split was to raise the per share trading price of our common stock to seek to maintain the listing of our common stock on The Nasdaq Capital Market. At the effective time of the reverse stock split, 5:00 p.m. on June 28, 2022, each 10 shares of our issued and outstanding common stock were automatically combined and converted into one issued and outstanding share of common stock. All of our stock options, restricted stock units ("RSUs") and warrants outstanding immediately prior to the reverse stock split, as well as the conversion ratio of our outstanding convertible preferred stock, were proportionately adjusted. All issued and outstanding common stock, options exercisable for common stock, restricted stock units, common stock issuable upon conversion of outstanding convertible preferred stock, warrants and per share amounts contained in our condensed financial statements have been retrospectively adjusted. Liquidity The accompanying financial statements have been prepared on a basis which assumes we are a going concern and does not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from any uncertainty related to our ability to continue as a going concern. Through June 30, 2023, we have principally been financed through proceeds received from the sale of our common stock and other equity securities, debt financings, up-front payments and milestones received from collaboration agreements, totaling $556.6 million. As of June 30, 2023, we had approximately $37.3 million of cash and cash equivalents. Based on our operating plans, we believe our cash and cash equivalents may not be sufficient to fund our operations for the period one year following the issuance of these financial statements. Specifically, we believe these existing resources will only be sufficient to fund our planned operations and expenditures into mid-2024. Our current liquidity position, recurring losses from operations since inception and negative cash flows from operating activities raise substantial doubt about our ability to continue as a going concern. As of June 30, 2023, w e are in compliance with all loan agreement covenants. We intend to seek additional capital through equity and/or debt financings, collaborative or other funding arrangements with partners or through other sources of financing. Should we seek additional financing from outside sources, we may not be able to raise such financing on terms acceptable to us or at all. If we are unable to raise additional capital when required or on acceptable terms, we may be required to scale back or discontinue the advancement of product candidates, reduce headcount, file for bankruptcy, reorganize, merge with another entity, or cease operations. If we are unable to continue as a going concern, we may have to liquidate our assets, and in doing so might realize significantly less for those assets than the values at which they are carried on our financial statements. Stockholders may lose all or part of their investment in our common stock. Use of Estimates Our condensed financial statements are prepared in accordance with GAAP, which requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in our financial statements and accompanying notes. An estimated loss contingency is accrued in our financial statements if it is probable that a liability has been incurred and the amount of the loss can be reasonably estimated. Although these estimates are based on our knowledge of current events and actions we may undertake in the future, actual results may ultimately differ from these estimates and assumptions. Stock-Based Compensation We account for stock-based compensation expense related to stock options granted to employees and members of our board of directors by estimating the fair value of each stock option on the date of grant using the Black-Scholes option pricing model. We recognize stock-based compensation expense using the accelerated multiple-option approach. Under the accelerated multiple-option approach (also known as the graded-vesting method), we recognize compensation expense over the requisite service period for each separately vesting tranche of the award as though the award was in substance multiple awards, resulting in accelerated expense recognition over the vesting period. For performance-based awards granted to employees (i) the fair value of the award is determined on the grant date, (ii) we assess the probability of the individual milestones under the award being achieved and (iii) the fair value of the shares subject to the milestone is expensed over the implicit service period commencing once management believes the performance criteria is probable of being met. We account for restricted stock units by determining the fair value of each restricted stock unit based on the closing market price of our common stock on the date of grant. We recognize stock-based compensation expense using the accelerated multiple-option approach over the requisite service periods of the awards. Clinical Trial and Preclinical Study Accruals We make estimates of our accrued expenses for clinical trial and preclinical study activities as of each balance sheet date in our financial statements based on the facts and circumstances known to us at that time. These accruals are based upon estimates of costs incurred and fees that may be associated with services provided by clinical trial investigational sites and CROs and for other clinical trial-related activities. Payments under certain contracts with such parties depend on factors such as successful enrollment of patients, site initiation and progression through the various stages of our clinical trials. In accruing for these services, we estimate the time period over which services will be performed and the level of effort to be expended in each period. If possible, we obtain information regarding unbilled services directly from these service providers. However, we may be required to estimate these services based on other information available to us. If we underestimate or overestimate the activities or fees associated with a study or service at a given point in time, adjustments to research and development expenses may be necessary in future periods. Historically, our estimated accrued liabilities have approximated actual expense incurred. Subsequent changes in estimates may result in a material change in our accruals. Prepaid Materials We capitalize the purchase of certain raw materials and related supplies for use in the manufacturing of drug product in our preclinical and clinical development programs, as we have determined that these materials have alternative future use. We can use these raw materials and related supplies in multiple clinical drug products, and therefore have future use independent of the development status of any particular program until it is utilized in the manufacturing process. We expense the cost of materials when used. We periodically review these capitalized materials for continued alternative future use and write down the asset to its net realizable value in the period in which an impairment is identified. Recent Accounting Pronouncements In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments . Subsequently, in November 2018, the FASB issued ASU 2018-19, Codification Improvements to Topic 326, Financial Instruments-Credit Losses . ASU 2016-13 requires entities to measure all expected credit losses for most financial assets held at the reporting date based on an expected loss model which includes historical experience, current conditions, an d reasonable and supportable forecasts. ASU 2016-13 also requires enhanced disclosures to help financial statement users better understand significant estimates and judgments used in estimating credit losses. This ASU is effective for smaller reporting companies for fiscal years beginning after Decem ber 15, 2022, with early adoption permitted. The adoption of this guidance had no impact on our financial statements and disclosures. In March 2020, the FASB issued ASU No. 2020-04, Reference Rate Reform (Topic 848), which provides guidance around reference rate reform initiatives to identify alternative reference rates that are more observable or transaction-based and less susceptible to manipulation in response to concerns about structural risks of interbank offered rates and the risk of cessation of the London Interbank Offered Rate ("LIBOR"). The amendments in the ASU provide option expedients and exceptions for applying GAAP to contracts, hedging relationships and other transactions affected by reference rate reform and apply only if such contracts, hedging relationships and other transactions that reference LIBOR or another reference rate are expected to be discontinued because of reference rate reform. On December 21, 2022, the FASB issued ASU No. 2022-06, Reference Rate Reform (Topic 848): Deferral of the Sunset Date of Topic 848, |
Net Loss Per Share
Net Loss Per Share | 6 Months Ended |
Jun. 30, 2023 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | Net Loss Per Share Basic net loss per share is calculated by dividing net loss by the weighted average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by dividing net loss by the weighted-average number of common share equiva lents outstanding for the period determined using the treasury stock method or if-converted method. Dilutive common stock equivalents are comprised of stock options, restricted stock units, warrants and convertible preferred stock outstanding. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted net loss per share. |
Investments
Investments | 6 Months Ended |
Jun. 30, 2023 | |
Debt Securities, Available-for-Sale [Abstract] | |
Investments | Investments Historically, we have invested our excess cash primarily in debt instruments of financial institutions, corporations, U.S. government-sponsored agencies and the U.S. Treasury. We generally hold our investments to maturity and do not sell our investments before we have recovered our amortized cost basis. As of June 30, 2023, our cash balance was comprised entirely of cash and cash equivalents (money market funds) and there was no unrealized gain or loss in the period. Unrealized Maturity (in years) Amortized cost Gains Losses Estimated fair value As of December 31, 2022 U.S. Treasury securities 1 or less $ 14,944 $ — $ (12) $ 14,932 $ 14,944 $ — $ (12) $ 14,932 |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements We have certain financial assets recorded at fair value which have been classified as Level 1, 2, or 3 within the fair value hierarchy as described in the accounting standards for fair value measurements. Accounting standards define fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants as of the measurement date. Market participants are buyers and sellers in the principal market that are (i) independent, (ii) knowledgeable, (iii) able to transact, and (iv) willing to transact. The accounting standards provide an established hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the most observable inputs be used when available. Observable inputs are inputs that market participants would use in valuing the asset or liability and are developed based on market data obtained from independent sources. Unobservable inputs are inputs that reflect our assumptions about the factors that market participants would use in valuing the asset or liability. The accounting standards prioritize the inputs used in measuring the fair value into the following hierarchy: • Level 1 includes financial instruments for which quoted market prices for identical instruments are available in active markets. • Level 2 includes financial instruments for which there are inputs other than quoted prices included within Level 1 that are observable for the instrument such as quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets with insufficient volume or infrequent transactions (less active markets) or model-driven valuations in which significant inputs are observable or can be derived principally from, or corroborated by, observable market data. • Level 3 includes financial instruments for which fair value is derived from valuation techniques in which one or more significant inputs are unobservable, including management’s own assumptions. Financial Assets Measured at Fair Value The following table presents our fair value hierarchy for assets measured at fair value on a recurring basis as of June 30, 2023 and December 31, 2022 (in thousands): Fair value as of June 30, 2023 Total Level 1 Level 2 Level 3 Cash equivalents: Money market funds $ 36,312 $ 36,312 $ — $ — $ 36,312 $ 36,312 $ — $ — Fair value as of December 31, 2022 Total Level 1 Level 2 Level 3 Cash equivalents and short-term investments: Money market funds $ 21,490 $ 21,490 $ — $ — U.S. Treasury securities 14,932 14,932 — — $ 36,422 $ 36,422 $ — $ — |
Debt
Debt | 6 Months Ended |
Jun. 30, 2023 | |
Debt Disclosure [Abstract] | |
Debt | Debt Term Loan On June 17, 2016, we entered into a loan and security agreement ("Loan Agreement") with Oxford Finance, LLC, (the “ Lender ” ), pursuant to which we received $20.0 million in proceeds, net of debt issuance costs, on June 22, 2016 (the "Term Loan"). The outstanding Term Loan bore interest at a floating per annum rate equal to (i) 8.51% plus (ii) the greater of (a) the 30 day U.S. Dollar LIBOR rate reported in The Wall Street Journal on the last business day of the month that immediately precedes the month in which the interest will accrue and (b) 0.44%. In June 2023, we entered into an amendment to the Loan Agreement (the “Rate Amendment”) pursuant to which, effective July 1, 2023, the Term Loan bears interest at a floating per annum rate equal to the greater of (a) 8.95% and (b) the sum of (i) the 1-month CME Term Secured Overnight Financing Rate ("SOFR") reference rate on the last business day of the month that immediately precedes the month in which the interest will accrue, (ii) 0.10% and (iii) 8.51%. Under the original Loan Agreement, we were required to make interest-only payments through June 1, 2018, followed by 24 equal monthly payments of principal and unpaid accrued interest. The Loan Agreement was amended ten times between October 2017 through August 2020. On December 31, 2021, we entered into an eleventh amendment to the Loan Agreement (the "Eleventh Amendment"). Under the terms of the Eleventh Amendment, the maturity date for the Term Loan was extended to May 1, 2024. In addition, under the Eleventh Amendment, our required monthly payments to the Lender were comprised of interest only through and including (i) December 1, 2022, if the 2022 Equity Event (as defined below) did not occur or (ii) December 1, 2023 if the 2022 Equity Event did occur. The “2022 Equity Event” meant the receipt by us, during the calendar year 2022, of unrestricted net cash proceeds of at least $20.0 million from the sale and issuance of our equity securities. The 2022 Equity Event did not occur. The Eleventh Amendment also provides that we are required to maintain a minimum cash balance of $5.0 million. As consideration for the Lender’s entry into the Eleventh Amendment, we made a payment of $0.3 million to the Lender. We used the proceeds from the Term Loan solely for working capital and to fund our general business requirements. Our obligations under the Loan Agreement are secured by a first priority security interest in substantially all of our current and future assets, other than our intellectual property, for which the Lender currently has a positive lien. We have also agreed not to encumber our intellectual property assets, except as permitted by the Loan Agreement. The Loan Agreement includes customary events of default, including instances of a material adverse change in our operations, that may require prepayment of the outstanding Term Loan. We are in compliance with all Loan Agreement covenants as of the date of the filing of this Form 10-Q. As of June 30, 2023 , $3.0 million o f principal was outstanding under the Term Loan. An additional $1.3 million is also payable at the conclusion of the Term Loan (the related $1.3 million accrued l iability balance is presented in other current liabilities on our balance sheet at June 30, 2023). We had less than $0.1 million of debt issuance costs outstanding as of June 30, 2023, which are being accreted to interest expense over the life of the Term Loan using an effective interest rate of 8.98%. The exit fees are being accrued over the life of the Term Loan through interest expense. As of June 30, 2023, future principal payments for the Term Loan due under the Loan Agreement are as follows (in thousands): 2023 $ 1,652 2024 1,377 $ 3,029 |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2023 | |
Equity [Abstract] | |
Stockholders' Equity | Stockholders’ Equity Common Stock As of June 30, 2023, the re were 19,484,461 shares of common stock outstanding. Each share of common stock is entitled to one vote. The holders of the common stock are also entitled to receive dividends whenever funds are legally available and when declared by our Board of Directors. Reverse Stock Split On June 24, 2022, we filed a Certificate of Amendment of Amended and Restated Certificate of Incorporation with the Secretary of State of the state of Delaware to effect a 1-for-10 reverse stock split of our issued and outstanding common stock. The primary purpose of the reverse stock split was to raise the per share trading price of our common stock to seek to maintain the listing of our common stock on The Nasdaq Capital Market. At the effective time of the reverse stock split, 5:00 p.m. on June 28, 2022, each 10 shares of our issued and outstanding common stock were automatically combined and converted into one issued and outstanding share of common stock. All of our stock options, RSUs and warrants outstanding immediately prior to the reverse stock split, as well as the conversion ratio of our outstanding convertible preferred stock, were proportionately adjusted. All issued and outstanding common stock, options exercisable for common stock, restricted stock units, common stock issuable upon conversion of outstanding convertible preferred stock, warrants a nd per share amounts contained in these financial statements have been retrospectively adjusted. 2019 Equity Incentive Plan On June 15, 2019, the Company's board of directors approved, and on August 1, 2019 the Company's stockholders approved, the Company's 2019 Equity Incentive Plan (the "2019 Plan"). The 2019 Plan is the successor to and continuation of the Company's 2012 Equity Incentive Plan . The number of shares authorized for issuance under the 2019 Plan may be increased by (a) the shares subject to outstanding stock awards granted under the Company’s 2009 Equity Incentive Plan (the “2009 Plan”) and the Company’s 2012 Equity Incentive Plan (together with the 2009 Plan, the “Prior Plans”) that on or after the effective date of the 2019 Plan (i) expire or terminate for any reason prior to exercise or settlement; (ii) are forfeited because of the failure to meet a contingency or condition required to vest such shares or otherwise return to the Company, or (iii) are reacquired, withheld (or not issued) to satisfy a tax withholding obligation in connection with an award or to satisfy the purchase price or exercise price of a stock award. No further grants will be made under the Prior Plan s. In addition, on January 22, 2020, an additional 416,686 shares of common stock became available for issuance under the 2019 Plan pursuant to the second closing under our May 2019 securities purchase agreement. Further, on January 1st of each year, for a period of not more than ten years, beginning on January 1, 2021 and continuing through January 1, 2029, the number of shares authorized for issuance under the 2019 Plan will increase by 5.0% of the total number of shares of our capital stock outstanding on December 31 of the preceding calendar year, or a lesser number of shares as may be determined by our Board of Directors. In addition, on June 13, 2023, our stockholders approved an amendment to the 2019 Plan, which authorized an additional 5,000,000 shares of common stock available for issuance thereunder. As of June 30, 2023, 5,237,056 shares of common stock were available for new equity award grants under the 2019 Plan and 2,931,353 shares of common stock were reserved for issuance pursuant to equity awards outstanding under the 2019 Plan as of June 30, 2023. 2021 Inducement Plan On November 23, 2021, our Board of Directors adopted the 2021 Inducement Plan (the “Inducement Plan”), which became effective immediately. Stockholder approval of the Inducement Plan was not required pursuant to Rule 5635I(4) of the Nasdaq Listing Rules. The Inducement Plan initially reserved 200,000 shares of common stock and provides for the grant of non-qualified stock options that was used exclusively for grants to individuals that were not previously employees or directors of the Company, as an inducement material to the individual’s entry into employment with the Company. The authorized number of shares available for grant under the Inducement Plan was subsequently increased in October 2022 to 540,000 shares in the aggregate. Under the Inducement Plan, options are granted with varying vesting terms, but typically vested over four years, with 25% of the total grant vesting on the first anniversary of the effective date of the option grant and the remaining grant vesting monthly thereafter over the following 36 months. As of June 30, 2023, 10,000 shares of common stock were reserved for future issuance under the Inducement Plan and 530,000 shares of common stock were reserved for future issuance pursuant to equity awards outstanding under the Inducement Plan. 2022 Employee Stock Purchase Plan In June 2022, our stockholders approved and we adopted the 2022 Employee Stock Purchase Plan (the “2022 Purchase Plan”), which enables participants to contribute up to 15% of such participant’s eligible compensation during a defined rolling six-month periods to purchase our common stock. The purchase price of common stock under the 2022 Purchase Plan will be the lesser of: (i) 85% of the fair market value of our common stock at the inception of the enrollment period or (ii) 85% of the fair market value of our common stock at the applicable purchase date. The 2022 Purchase Plan supersedes the 2012 Employee Stock Purchase Plan, and no further offerings will be made under the 2012 Employee Stock Purchase Plan. As of June 30 2023, a maximum of 159,635 shares of our common stock were reserved for future issuance and have been authorized for purchase under the 2022 Purchase Plan. 2023 Private Placement of Common Stock and Non-Voting Preferred Stock On April 13, 2023, we entered into a Securities Purchase Agreement (the “April 2023 SPA”) with certain institutional and other accredited investors (the “2023 Purchasers”), pursuant to which we agreed to sell and issue shares of our common stock and shares of our newly designated non-voting convertible preferred stock in a private placement transaction (the "2023 PIPE"). At the closing under the April 2023 SPA that occurred on April 13, 2023 (the “2023 Closing”), we sold and issued to the 2023 Purchasers (i) 2,615,536 shares of common stock at a purchase price of $0.9001 per share, and (ii) 140,827 shares of non-voting Class A-5 convertible preferred stock, in lieu of shares of common stock, at a price of $90.01 per share. Total gross proceeds from the 2023 Closing were approximately $15.0 million. Each share of non-voting Class A-5 convertible preferred stock is convertible into 100 shares of common stock, subject to certain beneficial ownership conversion limitations. An aggregate of 222,198 shares of common stock were purchased for $0.2 million by a director of the Company at the 2023 Closing. We evaluated the non-voting Class A-5 convertible preferred stock sold in the 2023 PIPE under ASC 480, Distinguishing Liabilities from Equity, and ASC 815, Derivatives and Hedging, and determined permanent equity treatment was appropriate for these freestanding financial instruments and there were no embedded features that required bifurcation. Additional Outstanding Non-Voting Preferred Stock and Warrants In May 2019, we sold and issued (i) 973,045 shares of common stock (ii) 415,898 shares of non-voting Class A-1 convertible preferred stock and (iii) accompanying warrants to purchase an aggregate of 1,388,943 shares of common stock. Each share of non-voting Class A-1 convertible preferred stock is convertible into one share of common stock, subject to certain beneficial ownership conversion limitations. The warrants are exercisable for a period of five years following the date of issuance and have an exercise price of $10.80 per share, subject to proportional adjustments in the event of stock splits or combinations or similar events. The warrants are also exercisable on a net exercise "cashless" basis. In December 2019, we sold and issued 3,288,390 shares of non-voting Class A-2 convertible preferred stock and accompanying warrants to purchase an aggregate of 3,288,390 shares of common stock. Each share of non-voting Class A-2 convertible preferred stock is convertible into one share of common stock, subject to certain beneficial ownership conversion limitations. The warrants will be exercisable for a period of five years following the date of issuance and have an exercise price of $6.66 per share, subject to proportional adjustments in the event of stock splits or combinations or similar events. The warrants are also exercisable on a net exercise “cashless” basis. In December 2020, we sold and issued (i) 2,434,152 shares of common stock (ii) 272,970 shares of non-voting Class A-3 convertible preferred stock and (iii) accompanying warrants to purchase an aggregate of 2,030,341 shares of common stock. Each share of non-voting Class A-3 convertible preferred stock is convertible into one share of common stock, subject to certain beneficial ownership conversion limitations. The warrants are exercisable for a period of five years following the date of issuance and have an exercise price of $7.46 per share, subject to proportional adjustments in the event of stock splits or combinations or similar events. The warrants are also exercisable on a net exercise "cashless" basis. In November 2021, we sold and issued (i) 5,892,335 shares of common stock and (ii) 3,725,720 shares of non-voting Class A-4 convertible preferred stock. Each share of non-voting Class A-4 convertible preferred stock is convertible into one share of common stock, subject to certain beneficial ownership conversion limitations. ATM Offering On December 12, 2018, we entered into a Common Stock Sales Agreement (the “Stock Sales Agreement”) with H.C. Wainwright & Co., LLC (“HCW”), pursuant to which we may sell and issue shares of our common stock from time to time through HCW, as our sales agent (the “ATM Offering”). We have no obligation to sell any shares of common stock in the ATM Offering, and may, at any time suspend offers under the Stock Sales Agreement or terminate the Stock Sales Agreement. Subject to the terms and conditions of the Stock Sales Agreement, HCW will use its commercially reasonable efforts to sell shares of our common stock from time to time based upon our instructions (including any price, time or size limits or other parameters or conditions that we may impose, subject to certain restrictions). We pay HCW a commission of 3.0% of the gross sales price of any shares sold under the Stock Sales Agreement. On August 10, 2021, we increased the amount of common stock available for sale in the ATM Offering under the Stock Sales Agreement to $50.0 million. A total of 9,192 shares were sold and settled for proceeds of less than $0.1 million under the ATM Offering during the three and six months ended June 30, 2023. No shares were sold under the ATM Offering during the six months ended June 30, 2022. At June 30, 2023, approximately $45.3 million remained eligible to be sold in the ATM Offering, subject to compliance with the rules applicable to sales on Form S-3. Shares Reserved for Future Issuance The following shares of common stock were reserved for future issuance as of June 30, 2023 (in thousands): Class A-1 convertible preferred stock outstanding (as-converted) 257 Class A-2 convertible preferred stock outstanding (as-converted) 1,331 Class A-3 convertible preferred stock outstanding (as-converted) 259 Class A-4 convertible preferred stock outstanding (as-converted) 3,726 Class A-5 convertible preferred stock outstanding (as-converted) 14,083 Warrants to purchase common stock 6,186 Common stock options outstanding 2,721 RSUs outstanding 210 Common stock available for future grant under the 2019 Equity Incentive Plan 5,237 Common stock available for future grant under the 2021 Inducement Plan 10 2022 Employee Stock Purchase Plan 160 Total common shares reserved for future issuance 34,180 The following table summarizes our stock option and RSU (together, "Stock Awards") activity under all equity incentive plans for the six months ended June 30, 2023 (shares in thousands): Number of Weighted Number of Weighted average grant date fair value Stock Awards outstanding at December 31, 2022 1,372 $ 7.53 70 $ 2.57 Granted 1,452 $ 1.46 210 $ 1.48 Exercised (options) or Vested (RSUs) — $ — — $ — Canceled/forfeited/expired (103) $ 6.01 (70) $ 2.57 Stock Awards outstanding at June 30, 2023 2,721 $ 4.34 210 $ 1.48 Stock-Based Compensation The following table summarizes the weighted average assumptions used to estimate the fair value of stock options and performance stock awards granted to employees under our 2019 Equity Incentive Plan, 2021 Inducement Plan and the shares purchasable under our Employee Stock Purchase Plans during the periods presented: Three months ended Six months ended 2023 2022 2023 2022 Stock options Risk-free interest rate 4.1 % 3.0 % 3.8 % 2.0 % Volatility 96.7 % 97.5 % 96.6 % 96.1 % Dividend yield — — — — Expected term (years) 6.1 6.1 6.1 6.1 Employee stock purchase plan shares Risk-free interest rate 4.9 % 0.8 % 4.5 % 0.5 % Volatility 71.8 % 98.4 % 88.1 % 96.1 % Dividend yield — — — — Expected term (years) 0.5 0.5 0.5 0.5 The following table summarizes the allocation of our stock-based compensation expense for all stock awards during the periods presented (in thousands): Three months ended Six months ended 2023 2022 2023 2022 Research and development $ 154 $ 100 $ 327 $ 370 General and administrative 228 321 465 1,055 Total $ 382 $ 421 $ 792 $ 1,425 |
Collaborations
Collaborations | 6 Months Ended |
Jun. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Collaborations | Collaborations Sanofi In February 2014, we and Sanofi entered into a second amended and restated collaboration and license agreement (the “Sanofi Agreement”) to discover, develop and commercialize micro RNA therapeutics to focus on specific orphan disease and oncology targets. Under the terms of the Sanofi Agreement, Sanofi had opt-in rights to our clinical fibrosis program targeting miR-21 for the treatment of Alport syndrome (which rights were relinquished by Sanofi in November 2018), our preclinical program targeting miR-21 for oncology indications, and our preclinical program targeting miR-221/222 for HCC. We were responsible for developing each of these programs to proof-of-concept, at which time Sanofi had an exclusive option on each program. We were eligible to receive royalties on micro RNA therapeutic products commercialized by Sanofi and would have had have the right to co-promote these products relating to our preclinical program targeting miR-221/222. |
Leases
Leases | 6 Months Ended |
Jun. 30, 2023 | |
Leases [Abstract] | |
Leases | Leases At the inception of a contractual arrangement, we determine whether the contract contains a lease by assessing whether there is an identified asset and whether the contract conveys the right to control the use of the identified asset in exchange for consideration over a period of time. For operating leases with an initial term greater than 12 months, we recognize operating lease right of use assets ("ROU assets") and operating lease liabilities based on the present value of lease payments over the lease term at the commencement date. Operating lease ROU assets are comprised of the lease liability plus any lease payments made and excludes lease incentives. Lease terms include options to renew or terminate the lease when we are reasonably certain that the renewal option will be exercised or when it is reasonably certain that the termination option will not be exercised. For our operating leases, we generally cannot determine the interest rate implicit in the lease, in which case we use our incremental borrowing rate as the discount rate for the lease. We estimate our incremental borrowing rate for our operating leases based on what we would normally pay to borrow on a collateralized basis over a similar term for an amount equal to the lease payments. Operating lease expense is recognized on a straight-line basis over the lease term. Leases with a lease term of 12 months or less at inception are not recorded on the unaudited condensed balance sheet. Instead, we recognize lease expense for these leases on a straight-line basis over the lease term. Our lease agreements do not contain any material variable lease payments, residual value guarantees or restrictive covenants. Certain leases require us to pay taxes, insurance, utilities, and maintenance costs for the building, which do not represent lease components. We elected to not separate lease and non-lease components. On June 19, 2019, we entered into a lease agreement (the “Prior Lease”) with ARE SD Region No.44 LLC ("Landlord") for the lease of approximately 8,727 square feet of rentable area of the building located at 10628 Science Center Drive, Suite 225, San Diego, California 92121 (the “Prior Premises”). The commencement date of the Prior Lease was July 1, 2019 (the “Prior Commencement Date”). We used the Prior Premises as our principal executive offices and as a laboratory for research and development and other related uses. The term of the Prior Lease (the “Prior Initial Term”) was two years, six months, ending December 31, 2021. The base rent payments due for the Prior Premises were $0.4 million in 2020 and $0.4 million in 2021, net of certain rent abatement terms. We were also responsible for the payment of additional rent to cover our share of the annual operating expenses of the building, the annual tax expenses of the building and the annual utilities cost of the building. On July 1, 2019, we recorded a $0.8 million lease liability for the Prior Lease, which was calculated as the present value of future lease payments to be made under the Prior Lease. A $0.6 million ROU asset was also recorded on July 1, 2019, which represents the difference between the lease liability and the remaining $0.2 million deferred credit for the reduction of the lease liability under the operating lease agreement with Landlord dated February 25, 2019. On February 11, 2021, we entered into a lease agreement (the "Campus Point Lease") with ARE-SD Region No. 61, LLC (as successor in interest to ARE-SD Region No. 58, LLC) ("Campus Point Landlord"), for the lease of approximately 13,438 square feet of rentable area located at 4224 Campus Point Court, Suite 210, San Diego, California, 92121 (the "Campus Point Premises"). The commencement date of the Campus Point Lease was April 15, 2021. However, for accounting purposes the lease commencement date was February 11, 2021. We are using the Campus Point Premises as our principal executive offices and as a laboratory for research and development. The term of the Campus Point Lease (“Campus Point Initial Term”) is 60 months, ending April 30, 2026. The aggregate base rent due over the initial term of the Campus Point Lease is approximately $3.8 million. We are also responsible for the payment of additional amounts to cover our share of the annual operating expenses of the building, the annual tax expenses of the building and the utilities costs for the building. Under the Campus Point Lease, we are required to maintain a deposit of $61,591 in a specially designated bank account, which we recorded as restricted cash on our balance sheet at June 30, 2023 and December 31, 2022. On February 11, 2021, concurrently with entry into the Campus Point Lease, we entered into an Assignment and Assumption of Lease (the “Assignment Agreement”) with Turning Point Therapeutics, Inc. (“Assignee”) and a Consent to Assignment (the "Consent") with Landlord. Pursuant to the Assignment Agreement, we assigned all rights, title, and interest under the Prior Lease to Assignee and delivered the Prior Premises to Assignee on April 22, 2021. Pursuant to the Assignment Agreement, Assignee paid us $60,000 in non-refundable assignment consideration. Additionally, the Consent stipulates that we were not required to pay a fee pursuant to the Prior Lease in connection with the assignment. The execution of the Campus Point Lease, Consent, and Assignment Agreement resulted in a modification which was not accounted for as a separate contract. Rather, we accounted for the three contracts with Campus Point Landlord in combination, as they were entered into at the same time and negotiated as a package to achieve the same commercial objective. We accounted for a $0.2 million reduction in the lease liability for the Prior Lease as a deferred credit that is amortized as a reduction to rent expense over the term of the Campus Point Lease. A lease liability of less than $0.1 million and ROU asset of less than $0.1 million remained with respect to the Prior Lease and was fully amortized as of April 30, 2021. On February 11, 2021, we recorded a $3.2 million lease liability for the Campus Point Lease, which was calculated as the present value of future lease payments to be made under the Campus Point Lease. A $3.0 million ROU asset was also recorded on February 11, 2021, which represents the difference between the lease liability and the $0.2 million deferred credit for the reduction of the lease liability under the Prior Lease. Our future lease payments under operating leases at June 30, 2023 are as follows (in thousands): Operating Leases Remaining 2023 $ 392 2024 800 2025 824 2026 277 Total operating lease payments $ 2,293 Less: amount representing interest (191) Present value of obligations under operating leases 2,102 Less: current portion (681) Long-term operating lease obligations $ 1,421 |
Basis of Presentation and Sum_2
Basis of Presentation and Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying unaudited condensed financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and the instructions to Form 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In management’s opinion, the accompanying financial statements reflect all adjustments, consisting of normal recurring adjustments, considered necessary for a fair presentation of the results for the interim periods presented. Interim financial results are not necessarily indicative of results anticipated for the full year. These unaudited condensed financial statements should be read in conjunction with the audited financial statements and footnotes included in our Annual Report on Form 10-K for the year ended December 31, 2022, from which the balance sheet information herein was derived. On June 24, 2022, we filed a Certificate of Amendment of Amended and Restated Certificate of Incorporation with the Secretary of State of the state of Delaware to effect a 1-for-10 reverse stock split of our issued and outstanding common stock. The primary purpose of the reverse stock split was to raise the per share trading price of our common stock to seek to maintain the listing of our common stock on The Nasdaq Capital Market. At the effective time of the reverse stock split, 5:00 p.m. on June 28, 2022, each 10 shares of our issued and outstanding common stock were automatically combined and converted into one issued and outstanding share of common stock. All of our stock options, restricted stock units ("RSUs") and warrants outstanding immediately prior to the reverse stock split, as well as the conversion ratio of our outstanding convertible preferred stock, were proportionately adjusted. All issued and outstanding common stock, options exercisable for common stock, restricted stock units, common stock issuable upon conversion of outstanding convertible preferred stock, warrants and per share amounts contained in our condensed financial statements have been retrospectively adjusted. |
Use of Estimates | Use of EstimatesOur condensed financial statements are prepared in accordance with GAAP, which requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in our financial statements and accompanying notes. An estimated loss contingency is accrued in our financial statements if it is probable that a liability has been incurred and the amount of the loss can be reasonably estimated. Although these estimates are based on our knowledge of current events and actions we may undertake in the future, actual results may ultimately differ from these estimates and assumptions. |
Stock-Based Compensation | Stock-Based Compensation We account for stock-based compensation expense related to stock options granted to employees and members of our board of directors by estimating the fair value of each stock option on the date of grant using the Black-Scholes option pricing model. We recognize stock-based compensation expense using the accelerated multiple-option approach. Under the accelerated multiple-option approach (also known as the graded-vesting method), we recognize compensation expense over the requisite service period for each separately vesting tranche of the award as though the award was in substance multiple awards, resulting in accelerated expense recognition over the vesting period. For performance-based awards granted to employees (i) the fair value of the award is determined on the grant date, (ii) we assess the probability of the individual milestones under the award being achieved and (iii) the fair value of the shares subject to the milestone is expensed over the implicit service period commencing once management believes the performance criteria is probable of being met. We account for restricted stock units by determining the fair value of each restricted stock unit based on the closing market price of our common stock on the date of grant. We recognize stock-based compensation expense using the accelerated multiple-option approach over the requisite service periods of the awards. |
Clinical Trial and Preclinical Study Accruals | Clinical Trial and Preclinical Study Accruals We make estimates of our accrued expenses for clinical trial and preclinical study activities as of each balance sheet date in our financial statements based on the facts and circumstances known to us at that time. These accruals are based upon estimates of costs incurred and fees that may be associated with services provided by clinical trial investigational sites and CROs and for other clinical trial-related activities. Payments under certain contracts with such parties depend on factors such as successful enrollment of patients, site initiation and progression through the various stages of our clinical trials. In accruing for these services, we estimate the time period over which services will be performed and the level of effort to be expended in each period. If possible, we obtain information regarding unbilled services directly from these service providers. However, we may be required to estimate these services based on other information available to us. If we underestimate or overestimate the activities or fees associated with a study or service at a given point in time, adjustments to research and development expenses may be necessary in future periods. Historically, our estimated accrued liabilities have approximated actual expense incurred. Subsequent changes in estimates may result in a material change in our accruals. |
Prepaid Materials | Prepaid Materials We capitalize the purchase of certain raw materials and related supplies for use in the manufacturing of drug product in our preclinical and clinical development programs, as we have determined that these materials have alternative future use. We can use these raw materials and related supplies in multiple clinical drug products, and therefore have future use independent of the development status of any particular program until it is utilized in the manufacturing process. We expense the cost of materials when used. We periodically review these capitalized materials for continued alternative future use and write down the asset to its net realizable value in the period in which an impairment is identified. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments . Subsequently, in November 2018, the FASB issued ASU 2018-19, Codification Improvements to Topic 326, Financial Instruments-Credit Losses . ASU 2016-13 requires entities to measure all expected credit losses for most financial assets held at the reporting date based on an expected loss model which includes historical experience, current conditions, an d reasonable and supportable forecasts. ASU 2016-13 also requires enhanced disclosures to help financial statement users better understand significant estimates and judgments used in estimating credit losses. This ASU is effective for smaller reporting companies for fiscal years beginning after Decem ber 15, 2022, with early adoption permitted. The adoption of this guidance had no impact on our financial statements and disclosures. In March 2020, the FASB issued ASU No. 2020-04, Reference Rate Reform (Topic 848), which provides guidance around reference rate reform initiatives to identify alternative reference rates that are more observable or transaction-based and less susceptible to manipulation in response to concerns about structural risks of interbank offered rates and the risk of cessation of the London Interbank Offered Rate ("LIBOR"). The amendments in the ASU provide option expedients and exceptions for applying GAAP to contracts, hedging relationships and other transactions affected by reference rate reform and apply only if such contracts, hedging relationships and other transactions that reference LIBOR or another reference rate are expected to be discontinued because of reference rate reform. On December 21, 2022, the FASB issued ASU No. 2022-06, Reference Rate Reform (Topic 848): Deferral of the Sunset Date of Topic 848, |
Fair Value Measurement | Fair Value Measurements We have certain financial assets recorded at fair value which have been classified as Level 1, 2, or 3 within the fair value hierarchy as described in the accounting standards for fair value measurements. Accounting standards define fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants as of the measurement date. Market participants are buyers and sellers in the principal market that are (i) independent, (ii) knowledgeable, (iii) able to transact, and (iv) willing to transact. The accounting standards provide an established hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the most observable inputs be used when available. Observable inputs are inputs that market participants would use in valuing the asset or liability and are developed based on market data obtained from independent sources. Unobservable inputs are inputs that reflect our assumptions about the factors that market participants would use in valuing the asset or liability. The accounting standards prioritize the inputs used in measuring the fair value into the following hierarchy: • Level 1 includes financial instruments for which quoted market prices for identical instruments are available in active markets. • Level 2 includes financial instruments for which there are inputs other than quoted prices included within Level 1 that are observable for the instrument such as quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets with insufficient volume or infrequent transactions (less active markets) or model-driven valuations in which significant inputs are observable or can be derived principally from, or corroborated by, observable market data. • Level 3 includes financial instruments for which fair value is derived from valuation techniques in which one or more significant inputs are unobservable, including management’s own assumptions. |
Investments (Tables)
Investments (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Debt Securities, Available-for-Sale [Abstract] | |
Schedule of Debt Securities | Unrealized Maturity (in years) Amortized cost Gains Losses Estimated fair value As of December 31, 2022 U.S. Treasury securities 1 or less $ 14,944 $ — $ (12) $ 14,932 $ 14,944 $ — $ (12) $ 14,932 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Hierarchy for Assets and Liabilities Measured at Fair Value on Recurring Basis | The following table presents our fair value hierarchy for assets measured at fair value on a recurring basis as of June 30, 2023 and December 31, 2022 (in thousands): Fair value as of June 30, 2023 Total Level 1 Level 2 Level 3 Cash equivalents: Money market funds $ 36,312 $ 36,312 $ — $ — $ 36,312 $ 36,312 $ — $ — Fair value as of December 31, 2022 Total Level 1 Level 2 Level 3 Cash equivalents and short-term investments: Money market funds $ 21,490 $ 21,490 $ — $ — U.S. Treasury securities 14,932 14,932 — — $ 36,422 $ 36,422 $ — $ — |
Debt (Tables)
Debt (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Debt Disclosure [Abstract] | |
Debt Maturities | As of June 30, 2023, future principal payments for the Term Loan due under the Loan Agreement are as follows (in thousands): 2023 $ 1,652 2024 1,377 $ 3,029 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Equity [Abstract] | |
Common Stock Reserved for Future Issuance | The following shares of common stock were reserved for future issuance as of June 30, 2023 (in thousands): Class A-1 convertible preferred stock outstanding (as-converted) 257 Class A-2 convertible preferred stock outstanding (as-converted) 1,331 Class A-3 convertible preferred stock outstanding (as-converted) 259 Class A-4 convertible preferred stock outstanding (as-converted) 3,726 Class A-5 convertible preferred stock outstanding (as-converted) 14,083 Warrants to purchase common stock 6,186 Common stock options outstanding 2,721 RSUs outstanding 210 Common stock available for future grant under the 2019 Equity Incentive Plan 5,237 Common stock available for future grant under the 2021 Inducement Plan 10 2022 Employee Stock Purchase Plan 160 Total common shares reserved for future issuance 34,180 |
Summary of Stock Option Activity RSU | The following table summarizes our stock option and RSU (together, "Stock Awards") activity under all equity incentive plans for the six months ended June 30, 2023 (shares in thousands): Number of Weighted Number of Weighted average grant date fair value Stock Awards outstanding at December 31, 2022 1,372 $ 7.53 70 $ 2.57 Granted 1,452 $ 1.46 210 $ 1.48 Exercised (options) or Vested (RSUs) — $ — — $ — Canceled/forfeited/expired (103) $ 6.01 (70) $ 2.57 Stock Awards outstanding at June 30, 2023 2,721 $ 4.34 210 $ 1.48 |
Summary of Assumptions Used to Estimate Fair Value of Stock Options and Performance Stock and Employee Stock Purchase Plan | The following table summarizes the weighted average assumptions used to estimate the fair value of stock options and performance stock awards granted to employees under our 2019 Equity Incentive Plan, 2021 Inducement Plan and the shares purchasable under our Employee Stock Purchase Plans during the periods presented: Three months ended Six months ended 2023 2022 2023 2022 Stock options Risk-free interest rate 4.1 % 3.0 % 3.8 % 2.0 % Volatility 96.7 % 97.5 % 96.6 % 96.1 % Dividend yield — — — — Expected term (years) 6.1 6.1 6.1 6.1 Employee stock purchase plan shares Risk-free interest rate 4.9 % 0.8 % 4.5 % 0.5 % Volatility 71.8 % 98.4 % 88.1 % 96.1 % Dividend yield — — — — Expected term (years) 0.5 0.5 0.5 0.5 |
Summary of Stock-Based Compensation | The following table summarizes the allocation of our stock-based compensation expense for all stock awards during the periods presented (in thousands): Three months ended Six months ended 2023 2022 2023 2022 Research and development $ 154 $ 100 $ 327 $ 370 General and administrative 228 321 465 1,055 Total $ 382 $ 421 $ 792 $ 1,425 |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Leases [Abstract] | |
Operating Lease, Liability, Maturity | Our future lease payments under operating leases at June 30, 2023 are as follows (in thousands): Operating Leases Remaining 2023 $ 392 2024 800 2025 824 2026 277 Total operating lease payments $ 2,293 Less: amount representing interest (191) Present value of obligations under operating leases 2,102 Less: current portion (681) Long-term operating lease obligations $ 1,421 |
Basis of Presentation and Sum_3
Basis of Presentation and Summary of Significant Accounting Policies (Details) $ in Millions | 6 Months Ended | |
Jun. 24, 2022 | Jun. 30, 2023 USD ($) | |
Accounting Policies [Abstract] | ||
Reverse stock split ratio | 0.1 | |
Financing from sale proceeds, debt, and agreement revenues | $ 556.6 | |
Cash, cash equivalents and short-term investments | $ 37.3 |
Net Loss Per Share (Details)
Net Loss Per Share (Details) - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Earnings Per Share [Abstract] | ||||
Potentially dilutive securities not included in calculation of diluted net loss per share (in shares) | 28,772,824 | 13,233,238 | 20,758,912 | 13,233,238 |
Investments (Details)
Investments (Details) - USD ($) | Jun. 30, 2023 | Dec. 31, 2022 |
Debt Securities, Available-for-sale [Line Items] | ||
Amortized cost | $ 14,944,000 | |
Unrealized gains | 0 | |
Unrealized losses | (12,000) | |
Estimated fair value | 14,932,000 | |
U.S. Treasury securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized cost | 14,944,000 | |
Unrealized gains | $ 0 | 0 |
Unrealized losses | $ 0 | (12,000) |
Estimated fair value | $ 14,932,000 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Assets measured at fair value on a recurring basis | $ 36,312 | $ 36,422 |
Level 1 | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Assets measured at fair value on a recurring basis | 36,312 | 36,422 |
Level 2 | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Assets measured at fair value on a recurring basis | 0 | 0 |
Level 3 | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Assets measured at fair value on a recurring basis | 0 | 0 |
Money market funds | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Assets measured at fair value on a recurring basis | 36,312 | 21,490 |
Money market funds | Level 1 | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Assets measured at fair value on a recurring basis | 36,312 | 21,490 |
Money market funds | Level 2 | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Assets measured at fair value on a recurring basis | 0 | 0 |
Money market funds | Level 3 | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Assets measured at fair value on a recurring basis | $ 0 | 0 |
U.S. Treasury securities | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Assets measured at fair value on a recurring basis | 14,932 | |
U.S. Treasury securities | Level 1 | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Assets measured at fair value on a recurring basis | 14,932 | |
U.S. Treasury securities | Level 2 | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Assets measured at fair value on a recurring basis | 0 | |
U.S. Treasury securities | Level 3 | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Assets measured at fair value on a recurring basis | $ 0 |
Debt (Narrative) (Details)
Debt (Narrative) (Details) $ in Millions | 6 Months Ended | 12 Months Ended | 32 Months Ended | ||
Jun. 22, 2016 USD ($) | Jun. 17, 2016 payment | Jun. 30, 2023 USD ($) | Dec. 31, 2022 USD ($) | May 31, 2020 amendment | |
Debt Instrument [Line Items] | |||||
Number of times agreement was amended | amendment | 10 | ||||
Term Loan | |||||
Debt Instrument [Line Items] | |||||
Proceeds from borrowing under term loan | $ 20 | ||||
Stated interest rate, percentage | 8.51% | ||||
Number of monthly payments | payment | 24 | ||||
Debt fee | $ 1.3 | ||||
Long-term debt | 3 | ||||
Other long-term liabilities | 1.3 | ||||
Debt issuance costs | $ 0.1 | ||||
Debt instrument effective rate (as a percent) | 8.98% | ||||
Term Loan | London Interbank Offered Rate (LIBOR) | |||||
Debt Instrument [Line Items] | |||||
Basis spread on variable rate, percentage | 0.44% | ||||
Term Loan | Secured Overnight Financing Rate (SOFR) Overnight Index Swap Rate | Option One | |||||
Debt Instrument [Line Items] | |||||
Basis spread on variable rate, percentage | 8.95% | ||||
Term Loan | Secured Overnight Financing Rate (SOFR) Overnight Index Swap Rate | Option Two, First Contributor | |||||
Debt Instrument [Line Items] | |||||
Basis spread on variable rate, percentage | 0.10% | ||||
Term Loan | Secured Overnight Financing Rate (SOFR) Overnight Index Swap Rate | Option Two, Second Contributor | |||||
Debt Instrument [Line Items] | |||||
Basis spread on variable rate, percentage | 8.51% | ||||
Eleventh Amendment | |||||
Debt Instrument [Line Items] | |||||
Unrestricted net cash proceeds amount | $ 20 | ||||
Cash collateral for borrowed securities | $ 5 | ||||
Debt fee | $ 0.3 |
Debt (Future Principal Payments
Debt (Future Principal Payments) (Details) - Debt Financing Agreement Tranche A $ in Thousands | Jun. 30, 2023 USD ($) |
Debt Instrument [Line Items] | |
2023 | $ 1,652 |
2024 | 1,377 |
Long-term Debt | $ 3,029 |
Stockholders' Equity (Narrative
Stockholders' Equity (Narrative) (Details) $ / shares in Units, $ in Millions | 1 Months Ended | |||||||||||||||
Jun. 13, 2023 shares | Apr. 13, 2023 USD ($) $ / shares shares | Jun. 24, 2022 | Nov. 23, 2021 shares | Jan. 22, 2020 shares | Jun. 30, 2022 shares | Nov. 30, 2021 shares | Dec. 31, 2020 $ / shares shares | Dec. 31, 2019 $ / shares shares | May 31, 2019 $ / shares shares | Jun. 30, 2023 vote shares | Mar. 31, 2023 shares | Dec. 31, 2022 shares | Oct. 31, 2022 shares | Mar. 31, 2022 shares | Dec. 31, 2021 shares | |
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||
Common stock, shares outstanding (in shares) | 19,484,461 | 16,840,261 | ||||||||||||||
Common stock voting rights votes | vote | 1 | |||||||||||||||
Reverse stock split ratio | 0.1 | |||||||||||||||
Total common shares reserved for future issuance (in shares) | 34,180,000 | |||||||||||||||
Common stock | ||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||
Common stock, shares outstanding (in shares) | 14,634,414 | 19,484,461 | 16,859,733 | 16,840,261 | 14,598,114 | 14,597,118 | ||||||||||
2023 Closing | ||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||
Consideration received | $ | $ 15 | |||||||||||||||
2023 Closing | Common stock | ||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||
Share sold (in shares) | 2,615,536 | |||||||||||||||
Sale of stock price (in usd per share) | $ / shares | $ 0.9001 | |||||||||||||||
Shares issued upon conversion (in shares) | 100 | |||||||||||||||
Private Placement | ||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||
Share sold (in shares) | 5,892,335 | 2,434,152 | 973,045 | |||||||||||||
Nonvoting convertible preferred stock issued (in shares) | 415,898 | |||||||||||||||
Warrants callable (in shares) | 2,030,341 | |||||||||||||||
Class of warrant | 5 years | |||||||||||||||
Class A-5 Convertible Preferred Stock | 2023 Closing | ||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||
Share sold (in shares) | 140,827 | |||||||||||||||
Sale of stock price (in usd per share) | $ / shares | $ 90.01 | |||||||||||||||
Class A-1 Convertible Preferred Stock | Private Placement | ||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||
Warrants callable (in shares) | 1,388,943 | |||||||||||||||
Preferred Class A | Private Placement | ||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||
Sale of stock price (in usd per share) | $ / shares | $ 10.80 | |||||||||||||||
Shares issued upon conversion (in shares) | 1 | |||||||||||||||
Class A-2 Convertible Preferred Stock | 2019 PIPE Milestone Closing warrants | ||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||
Share sold (in shares) | 3,288,390 | |||||||||||||||
Shares issued upon conversion (in shares) | 1 | |||||||||||||||
Warrants callable (in shares) | 3,288,390 | |||||||||||||||
Class of warrant | 5 years | |||||||||||||||
Warrant exercise price (in usd per share) | $ / shares | $ 6.66 | |||||||||||||||
Class A-3 Convertible Preferred Stock | Private Placement | ||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||
Shares issued upon conversion (in shares) | 1 | 1 | ||||||||||||||
Nonvoting convertible preferred stock issued (in shares) | 3,725,720 | 272,970 | ||||||||||||||
Class of warrant | 5 years | |||||||||||||||
Warrant exercise price (in usd per share) | $ / shares | $ 7.46 | |||||||||||||||
Director | 2023 Closing | ||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||
Share sold (in shares) | 222,198 | |||||||||||||||
Director | Class A-4 Convertible Preferred Stock | 2023 Closing | ||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||
Consideration received | $ | $ 0.2 | |||||||||||||||
2019 Plan | ||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||
Number of additional shares authorized (in shares) | 5,000,000 | 416,686 | ||||||||||||||
Number of years for increase of authorized shares | 10 years | |||||||||||||||
Number of additional shares authorized yearly increase (as a percent) | 5% | |||||||||||||||
Common stock available for future grant (in shares) | 5,237,056 | |||||||||||||||
Total common shares reserved for future issuance (in shares) | 2,931,353 | |||||||||||||||
Inducement Plan | ||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||
Common stock available for future grant (in shares) | 10,000 | |||||||||||||||
Total common shares reserved for future issuance (in shares) | 200,000 | 530,000 | 540,000 | |||||||||||||
Vesting period | 4 years | |||||||||||||||
Inducement Plan | Share-based Payment Arrangement, Tranche One | ||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||
Award vesting percentage | 25% | |||||||||||||||
Inducement Plan | Share-based Payment Arrangement, Tranche Two | ||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||
Vesting period for remaining vesting rights | 36 months | |||||||||||||||
2022 ESPP | 2022 Employee Stock Purchase Plan | ||||||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||||||
Share-based compensation arrangement by share-based payment award, discount from market price, purchase date | 15% | |||||||||||||||
Share-based compensation arrangement by share-based payment award, purchase price of common stock, percent | 85% | |||||||||||||||
Share-based compensation arrangement by share-based payment award, number of shares authorized (in shares) | 159,635 |
Stockholders' Equity (ATM Offer
Stockholders' Equity (ATM Offering) (Details) - At The Moment - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2023 | Jun. 30, 2023 | Jun. 30, 2022 | Aug. 10, 2021 | Dec. 12, 2018 | |
Class of Stock [Line Items] | |||||
Commission fee rate (as a percent) | 3% | ||||
Share sold (in shares) | 9,192 | 9,192 | 0 | ||
Consideration received | $ 0.1 | $ 0.1 | |||
Amount eligible to be drawn down under the ATM | $ 45.3 | $ 45.3 | $ 50 |
Stockholders' Equity (Common St
Stockholders' Equity (Common Stock Reserved for Future Issuance) (Details) shares in Thousands | Jun. 30, 2023 shares |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Common stock options outstanding (in shares) | 2,721 |
Total common shares reserved for future issuance (in shares) | 34,180 |
Common stock available for future grant under the 2019 Equity Incentive Plan | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Common stock available for future grant (in shares) | 5,237 |
Common stock available for future grant under the 2021 Inducement Plan | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Common stock available for future grant (in shares) | 10 |
2022 Employee Stock Purchase Plan | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Common stock available for future grant (in shares) | 160 |
RSUs outstanding | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
RSUs outstanding (in shares) | 210 |
Warrants to purchase common stock | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Warrants outstanding (in shares) | 6,186 |
Class A-1 convertible preferred stock outstanding (as-converted) | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Preferred stock, shares outstanding (in shares) | 257 |
Class A-2 convertible preferred stock outstanding (as-converted) | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Preferred stock, shares outstanding (in shares) | 1,331 |
Class A-3 convertible preferred stock outstanding (as-converted) | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Preferred stock, shares outstanding (in shares) | 259 |
Class A-4 convertible preferred stock outstanding (as-converted) | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Preferred stock, shares outstanding (in shares) | 3,726 |
Class A-5 convertible preferred stock outstanding (as-converted) | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Preferred stock, shares outstanding (in shares) | 14,083 |
Stockholders' Equity (Stock Opt
Stockholders' Equity (Stock Option and RSU Activity) (Details) shares in Thousands | 6 Months Ended |
Jun. 30, 2023 $ / shares shares | |
Number of options | |
Ending balance (in shares) | 2,721 |
Stock options | |
Number of options | |
Beginning balance (in shares) | 1,372 |
Granted (in shares) | 1,452 |
Exercised (options) or Vested (RSUs) | 0 |
Canceled/forfeited/expired (in shares) | (103) |
Ending balance (in shares) | 2,721 |
Weighted average exercise price | |
Beginning balance (in usd per share) | $ / shares | $ 7.53 |
Granted (in usd per share) | $ / shares | 1.46 |
Exercised (options) or Vested (RSUs) (in usd per share) | $ / shares | 0 |
Canceled/forfeited/expired (in usd per share) | $ / shares | 6.01 |
Ending balance (in usd per share) | $ / shares | $ 4.34 |
Restricted Stock Units (RSUs) | |
Number of RSUs | |
Beginning balance (in shares) | 70 |
Shares granted (in shares) | 210 |
Exercised (options) or Vested (RSUs) (in shares) | 0 |
Canceled/forfeited/expired (in shares) | (70) |
Ending balance (in shares) | 210 |
Weighted average grant date fair value | |
Beginning balance (in usd per share) | $ / shares | $ 2.57 |
Granted (in usd per share) | $ / shares | 1.48 |
Exercised (options) or Vested (RSUs) (in usd per share) | $ / shares | 0 |
Canceled/forfeited/expired (in usd per share) | $ / shares | 2.57 |
Ending balance (in usd per share) | $ / shares | $ 1.48 |
Stockholders' Equity (Assumptio
Stockholders' Equity (Assumptions Used to Estimate Fair Value of Stock Options and Performance Stock and Employee Stock Purchase Plan) (Details) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Stock options | ||||
Weighted average assumptions | ||||
Risk-free interest rate | 4.10% | 3% | 3.80% | 2% |
Volatility | 96.70% | 97.50% | 96.60% | 96.10% |
Dividend yield | 0% | 0% | 0% | 0% |
Expected term (years) | 6 years 1 month 6 days | 6 years 1 month 6 days | 6 years 1 month 6 days | 6 years 1 month 6 days |
Employee stock purchase plan shares | ||||
Weighted average assumptions | ||||
Risk-free interest rate | 4.90% | 0.80% | 4.50% | 0.50% |
Volatility | 71.80% | 98.40% | 88.10% | 96.10% |
Dividend yield | 0% | 0% | 0% | 0% |
Expected term (years) | 6 months | 6 months | 6 months | 6 months |
Stockholders' Equity (Stock-Bas
Stockholders' Equity (Stock-Based Compensation Expense Allocation) (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expenses | $ 382 | $ 421 | $ 792 | $ 1,425 |
Research and development | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expenses | 154 | 100 | 327 | 370 |
General and administrative | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expenses | $ 228 | $ 321 | $ 465 | $ 1,055 |
Leases (Narrative) (Details)
Leases (Narrative) (Details) | Feb. 11, 2021 USD ($) ft² contract | Jun. 30, 2023 USD ($) | Dec. 31, 2022 USD ($) | Jun. 30, 2022 USD ($) | Dec. 31, 2021 USD ($) | Apr. 30, 2021 USD ($) | Dec. 31, 2020 USD ($) | Jul. 01, 2019 USD ($) | Jun. 19, 2019 ft² |
Lessee, Lease, Description [Line Items] | |||||||||
Remaining liability to be paid | $ 392,000 | ||||||||
Base rent payments due 2021 | 800,000 | ||||||||
ROU asset | 1,763,000 | $ 2,039,000 | |||||||
Operating lease payments due | 2,293,000 | ||||||||
Restricted cash | 62,000 | 62,000 | $ 62,000 | ||||||
Prior Premises | |||||||||
Lessee, Lease, Description [Line Items] | |||||||||
Net rentable area | ft² | 8,727 | ||||||||
Term of contract | 2 years 6 months | ||||||||
Remaining liability to be paid | $ 400,000 | ||||||||
Base rent payments due 2021 | $ 400,000 | ||||||||
Initial direct cost liability | $ 800,000 | ||||||||
ROU asset | 600,000 | ||||||||
Deferred credit, operating lease liabilities | $ 200,000 | ||||||||
Campus Point Lease | |||||||||
Lessee, Lease, Description [Line Items] | |||||||||
Term of contract | 60 months | ||||||||
Initial direct cost liability | $ 3,200,000 | $ 100,000 | |||||||
ROU asset | 3,000,000 | 100,000 | |||||||
Deferred credit, operating lease liabilities | $ 200,000 | ||||||||
Rented area | ft² | 13,438 | ||||||||
Operating lease payments due | $ 3,800,000 | ||||||||
Restricted cash | $ 61,591 | $ 61,591 | |||||||
Nonrefundable lease cost for assignment | $ 60,000 | ||||||||
Number of operating lease contracts | contract | 3 | ||||||||
Deferred cost of liability | $ 200,000 |
Leases (Operating and Finance M
Leases (Operating and Finance Maturities) (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Lessee, Operating Lease, Liability, Payment, Due [Abstract] | ||
Remaining 2023 | $ 392 | |
2024 | 800 | |
2025 | 824 | |
2026 | 277 | |
Total operating lease payments | 2,293 | |
Less: amount representing interest | (191) | |
Present value of obligations under operating leases | 2,102 | |
Less: current portion | (681) | |
Long-term operating lease obligations | $ 1,421 | $ 1,768 |