Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2022 | Aug. 12, 2022 | |
Entity Addresses [Line Items] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2022 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q2 | |
Trading Symbol | ALNA | |
Entity Registrant Name | ALLENA PHARMACEUTICALS, INC. | |
Entity Central Index Key | 0001624658 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Shell Company | false | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true | |
Entity Common Stock, Shares Outstanding | 122,083,226 | |
Entity File Number | 001-38268 | |
Entity Tax Identification Number | 45-2729920 | |
Entity Address, Address Line One | 142-F North Road | |
Entity Address, Address Line Two | Suite 150 | |
Entity Address, City or Town | Sudbury | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 01776 | |
City Area Code | 617 | |
Local Phone Number | 467-4577 | |
Title of 12(b) Security | Common Stock, par value $0.001 per share | |
Security Exchange Name | NASDAQ | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity Incorporation, State or Country Code | DE | |
Former Address | ||
Entity Addresses [Line Items] | ||
Entity Address, Address Line One | One Newton Executive Park | |
Entity Address, Address Line Two | Suite 202 | |
Entity Address, City or Town | Newton | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 02462 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (unaudited) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 6,589 | $ 29,988 |
Prepaid expenses and other current assets | 9,897 | 3,018 |
Total current assets | 16,486 | 33,006 |
Property and equipment, net | 930 | 1,173 |
Operating lease assets | 272 | 455 |
Other assets | 123 | 123 |
Total assets | 17,811 | 34,757 |
Current liabilities: | ||
Accounts payable | 2,271 | 1,030 |
Loan payable, net of discount | 4,904 | 9,852 |
Accrued expenses and other current liabilities | 2,870 | 4,480 |
Operating lease liabilities, net of discount | 380 | 317 |
Total current liabilities | 10,425 | 15,679 |
Warrant liability | 3,645 | |
Operating lease liabilities, net of current portion and discount | 210 | |
Total liabilities | 14,070 | 15,889 |
Commitments and contingencies (Note 6) | ||
Stockholders’ equity: | ||
Undesignated preferred stock, $0.001 par value; 5,000,000 shares authorized; 2,872 shares issued and no shares outstanding at June 30, 2022; no shares issued and outstanding at December 31, 2021 | ||
Common stock, $0.001 par value; 200,000,000 shares authorized; 107,725,169 and 82,969,421 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively | 108 | 83 |
Additional paid-in capital | 270,333 | 265,237 |
Accumulated deficit | (266,700) | (246,452) |
Total stockholders’ equity | 3,741 | 18,868 |
Total liabilities and stockholders’ equity | $ 17,811 | $ 34,757 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) (unaudited) - $ / shares | Jun. 30, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Undesignated preferred stock, par value | $ 0.001 | $ 0.001 |
Undesignated preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Undesignated preferred stock, shares issued | 2,872 | 0 |
Undesignated preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 107,725,169 | 82,969,421 |
Common stock, shares outstanding | 107,725,169 | 82,969,421 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Operating expenses: | ||||
Research and development | $ 3,981 | $ 10,090 | $ 11,739 | $ 17,942 |
General and administrative | 2,943 | 3,597 | 6,742 | 7,155 |
Total operating expenses | 6,924 | 13,687 | 18,481 | 25,097 |
Loss from operations | (6,924) | (13,687) | (18,481) | (25,097) |
Other income (expense): | ||||
Loss on issuance of securities | (371) | (371) | ||
Change in valuation of warrant liability | (1,023) | (1,023) | ||
Interest expense, net | (118) | (253) | (367) | (488) |
Other income (expense), net | 1 | (32) | (6) | (23) |
Other expense, net | (1,511) | (285) | (1,767) | (511) |
Net loss | $ (8,435) | $ (13,972) | $ (20,248) | $ (25,608) |
Net loss per share attributable to common stockholders-basic | $ (0.08) | $ (0.24) | $ (0.21) | $ (0.45) |
Net loss per share attributable to common stockholders-diluted | $ (0.08) | $ (0.24) | $ (0.21) | $ (0.45) |
Weighted-average common share outstanding-basic | 100,623,730 | 57,932,389 | 95,034,212 | 56,484,811 |
Weighted-average common share outstanding-diluted | 100,623,730 | 57,932,389 | 95,034,212 | 56,484,811 |
Comprehensive loss | $ (8,435) | $ (13,972) | $ (20,248) | $ (25,608) |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity (unaudited) - USD ($) $ in Thousands | Total | Series D Convertible Preferred Stock | Series E Convertible Preferred Stock | Common Stock | Additional Paid-in Capital | Accumulated Deficit |
Balance at Dec. 31, 2020 | $ 22,569 | $ 51 | $ 220,307 | $ (197,789) | ||
Balance, Shares at Dec. 31, 2020 | 50,821,361 | |||||
Balance at Mar. 31, 2021 | 23,503 | $ 57 | 232,871 | (209,425) | ||
Balance, Shares at Mar. 31, 2021 | 56,879,679 | |||||
Balance at Dec. 31, 2020 | 22,569 | $ 51 | 220,307 | (197,789) | ||
Balance, Shares at Dec. 31, 2020 | 50,821,361 | |||||
Issuance of common stock, net of issuance costs | 13,474 | $ 8 | 13,466 | |||
Issuance of common stock, net of issuance costs, shares | 7,709,306 | |||||
Issuance of common stock through employee stock purchase plan ("ESPP") | 5 | 5 | ||||
Issuance of common stock through employee stock purchase plan ("ESPP"), shares | 4,206 | |||||
Issuance of common stock through release of restricted stock units ("RSUs"), shares | 248,111 | |||||
Stock-based compensation | 1,827 | 1,827 | ||||
Net loss | (25,608) | (25,608) | ||||
Balance at Jun. 30, 2021 | 12,267 | $ 59 | 235,605 | (223,397) | ||
Balance, Shares at Jun. 30, 2021 | 58,782,984 | |||||
Balance at Mar. 31, 2021 | 23,503 | $ 57 | 232,871 | (209,425) | ||
Balance, Shares at Mar. 31, 2021 | 56,879,679 | |||||
Issuance of common stock, net of issuance costs | 1,771 | $ 2 | 1,769 | |||
Issuance of common stock, net of issuance costs, shares | 1,650,988 | |||||
Issuance of common stock through employee stock purchase plan ("ESPP") | 5 | 5 | ||||
Issuance of common stock through employee stock purchase plan ("ESPP"), shares | 4,206 | |||||
Issuance of common stock through release of restricted stock units ("RSUs"), shares | 248,111 | |||||
Stock-based compensation | 960 | 960 | ||||
Net loss | (13,972) | (13,972) | ||||
Balance at Jun. 30, 2021 | 12,267 | $ 59 | 235,605 | (223,397) | ||
Balance, Shares at Jun. 30, 2021 | 58,782,984 | |||||
Balance at Dec. 31, 2021 | $ 18,868 | $ 83 | 265,237 | (246,452) | ||
Balance, Shares at Dec. 31, 2021 | 82,969,421 | 82,969,421 | ||||
Balance at Mar. 31, 2022 | $ 11,616 | $ 90 | 269,791 | (258,265) | ||
Balance, Shares at Mar. 31, 2022 | 89,774,309 | |||||
Balance at Dec. 31, 2021 | $ 18,868 | $ 83 | 265,237 | (246,452) | ||
Balance, Shares at Dec. 31, 2021 | 82,969,421 | 82,969,421 | ||||
Issuance of convertible preferred stock and warrants, net of issuance costs, shares | 1,436 | 1,436 | ||||
Conversion of preferred stock into common stock | $ 18 | (18) | ||||
Conversion of preferred stock into common stock, shares | (1,436) | (1,436) | 17,950,860 | |||
Issuance of common stock, net of issuance costs | $ 3,944 | $ 7 | 3,937 | |||
Issuance of common stock, net of issuance costs, shares | 6,804,888 | |||||
Stock-based compensation | 1,177 | 1,177 | ||||
Net loss | (20,248) | (20,248) | ||||
Balance at Jun. 30, 2022 | $ 3,741 | $ 108 | 270,333 | (266,700) | ||
Balance, Shares at Jun. 30, 2022 | 107,725,169 | 107,725,169 | ||||
Balance at Mar. 31, 2022 | $ 11,616 | $ 90 | 269,791 | (258,265) | ||
Balance, Shares at Mar. 31, 2022 | 89,774,309 | |||||
Issuance of convertible preferred stock and warrants, net of issuance costs, shares | 1,436 | 1,436 | ||||
Conversion of preferred stock into common stock | $ 18 | (18) | ||||
Conversion of preferred stock into common stock, shares | (1,436) | (1,436) | 17,950,860 | |||
Stock-based compensation | 560 | 560 | ||||
Net loss | (8,435) | (8,435) | ||||
Balance at Jun. 30, 2022 | $ 3,741 | $ 108 | $ 270,333 | $ (266,700) | ||
Balance, Shares at Jun. 30, 2022 | 107,725,169 | 107,725,169 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (unaudited) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Cash flows from operating activities: | ||
Net loss | $ (20,248) | $ (25,608) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 1,177 | 1,827 |
Depreciation expense | 243 | 145 |
Loss on issuance of securities | 371 | |
Change in valuation of warrant liability | 1,023 | |
Non-cash interest expense | 52 | 27 |
Non-cash lease expense | 189 | 190 |
Changes in assets and liabilities: | ||
Prepaid expenses and other current assets | (6,879) | 542 |
Other assets | (50) | |
Accounts payable | 1,241 | 124 |
Accrued expenses | (1,610) | 1,555 |
Operating lease liabilities | (153) | (150) |
Net cash used in operating activities | (24,594) | (21,398) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (457) | |
Net cash used in investing activities | (457) | |
Cash flows from financing activities: | ||
Proceeds from the issuance of common stock, net of issuance costs | 3,944 | 13,464 |
Proceeds from the issuance of convertible preferred stock, net of issuance costs | 2,251 | |
Proceeds from issuance of stock through ESPP | 5 | |
Repayment of loan payable | (5,000) | |
Net cash provided by financing activities | 1,195 | 13,469 |
Net decrease in cash and cash equivalents | (23,399) | (8,386) |
Cash and cash equivalents, beginning of period | 29,988 | 35,042 |
Cash and cash equivalents, end of period | $ 6,589 | 26,656 |
Supplemental disclosures: | ||
Issuance costs included in accounts payable and accrued expenses | $ 10 |
Nature of Business
Nature of Business | 6 Months Ended |
Jun. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of Business | 1. Nature of Business Allena Pharmaceuticals, Inc. (the “Company”) is a clinical stage company focused on developing non-absorbed oral enzyme therapeutics to treat metabolic conditions including hyperuricemia and gout. The Company was incorporated under the laws of the State of Delaware on June 24, 2011. The Company’s headquarters are in Sudbury, Massachusetts. The Company is subject to risks common to companies in the biotechnology industry, including but not limited to, risks of failure of preclinical studies and clinical trials, the need to obtain marketing approval for any drug product candidate that it may identify and develop, the need to successfully commercialize and gain market acceptance of its product candidates, dependence on key personnel, protection of proprietary technology, compliance with government regulations, development by competitors of technological innovations, reliance on third party manufacturers, ability to transition from pilot-scale manufacturing to large-scale production of products and the need to obtain adequate additional financing to fund the development of its product candidates. Liquidity and Going Concern The Company had an accumulated deficit of $ 266.7 million at June 30, 2022 and will require substantial additional capital to fund operations. The future success of the Company is dependent on its ability to identify and develop its product candidates and ultimately upon its ability to attain profitable operations. At June 30, 2022, the Company had $ 6.6 million of cash and cash equivalents. The Company’s available cash and cash equivalents as of June 30, 2022 are not sufficient to fund the Company’s current operating plan for at least the next twelve months following the filing of this Quarterly Report. The Company requires additional capital to sustain its operations, including its ALLN-346 development program. Management is exploring opportunities to secure additional funding through equity or debt financings or through collaborations, licensing transactions or other sources. In January 2022, the Company initiated a process to explore a range of strategic and financing alternatives to maximize stockholder value and has engaged the investment bank Stifel, Nicolaus & Company, Inc. ("Stifel") to act as strategic advisor for this process. Potential strategic alternatives that may be evaluated include a partnership or sale of ALLN-346, a sale or merger of the Company, or securing additional financing to enable further development of the Company's ALLN-346 program. There can be no assurance that this strategic review process will result in the Company pursuing any transaction or that any transaction, if pursued, will be completed. If the Company is unable to complete a transaction, it may be required to seek an in-court or out-of-court restructuring of its liabilities. As part of the strategic process, the Compensation Committee of the Board of Directors approved a retention plan on January 28, 2022, available to all employees (the "Retention Plan"). Employees were required to execute retention agreements to receive payments and other considerations offered by the Retention Plan. Employees who executed a retention agreement received a salary adjustment equal to 6.5 % retroactive to January 1, 2022, a restricted stock unit ("RSU") grant and a lump sum retention payment. A total of 2,998,500 RSUs were granted on February 1, 2022 under the Retention Plan. Lump sum retention payments totaling $ 3.0 million were made to employees in February 2022. If an employee resigns from the Company or is terminated for cause prior to June 30, 2022, the employee would be required to fully repay the lump sum retention payment received. If an employee resigns from the Company or is terminated for cause between July 1, 2022 and September 30, 2022, the employee would be required to repay 50 % of the lump sum retention payment received. During the first quarter of 2022, the Company made voluntary principal repayments of $ 5.0 million of the $ 10.0 million that was outstanding as of December 31, 2021 under the loan and security agreement with Pontifax Medison Finance (Israel) L.P. and Pontifax Medison Finance (Cayman) L.P. (together “Pontifax”) (the “Pontifax Agreement”). The Company made an additional voluntary principal repayment of $ 0.5 million in August 2022. The outstanding principal balance as of the filing date of this Quarterly Report is $ 4.5 million. The Company also purchased Directors' & Officers' run-off insurance for $ 6.8 million in March 2022. On March 18, 2022, the Company announced that it was terminating its URIROX-2 study and reloxaliase program and initiated the process of closing the URIROX-2 study with the CRO, investigative sites, patients and business partners. In connection with the termination of the reloxaliase program, the Company completed a workforce reduction of approximately 40 % on March 31, 2022. In accordance with the terms of the Retention Plan, the employees terminated by the Company on March 31, 2022 were not required to repay any portion of their lump sum retention payments originally received in February 2022. During the first quarter of 2022, the Company issued and sold 6,804,888 shares of its common stock under an At-Market Issuance Sales Agreement with B. Riley Securities, Inc. at a weighted average price of $ 0.62 per share for net proceeds of $ 3.9 million. On May 3, 2022, the Company entered into a securities purchase agreement with an investor, pursuant to which the Company agreed to issue, in a registered direct offering, an aggregate of 2,872.1376 shares of Preferred Stock (split evenly between the Series D Convertible Preferred Stock, par value $ 0.001 per share (“Series D Preferred Stock”), and Series E Convertible Preferred Stock, par value $ 0.001 per share (“Series E Preferred Stock” and together with the Series D Preferred Stock, the “Preferred Stock”)). The Company received net proceeds of approximately $ 2.3 million from the issuance and sale of the Preferred Stock, after deducting offering expenses and placement agent fees. The shares of Preferred Stock have a stated value of $ 1,000 per share and are convertible, following the date of the issuance thereof, into an aggregate of 8,975,430 shares of common stock of the Company upon the conversion of the Series D Preferred Stock and into an aggregate of 8,975,430 shares of common stock of the Company upon the conversion of the Series E Preferred Stock, in each case, at a conversion price of $ 16.00 per share. H.C. Wainwright & Co., LLC (“HCW”) was the exclusive placement agent for this offering. On May 5, 2022, the Preferred Stock investor converted all of its Series D Preferred Stock into 8,975,430 shares of common stock, and on May 9, 2022, the Preferred Stock investor converted all of its Series E Preferred Stock into 8,975,430 shares of common stock. In a concurrent private placement, the Company also issued to the Preferred Stock investor unregistered warrants (the “2022 Common Warrants”) to purchase up to an aggregate of 22,438,575 shares of the Company’s common stock, at an exercise price of $ 0.1694 per share. The 2022 Common Warrants will become exercisable six months after the date of issuance, and will have a term of five years from the initial exercise date. The Company also issued to designees of HCW, in a concurrent private placement, warrants to purchase up to 1,256,561 shares of Common Stock (the “HCW Warrants”). The HCW Warrants are exercisable for $ 0.20 per share and will be exercisable six months after the date of issuance and have a term of five years from the commencement of sales pursuant to the registered direct offering. The Company entered into an At Market Offering Agreement with H.C. Wainwright & Co., LLC (“HCW ATM Agreement”) on July 8, 2022. Since that time and through the filing date of this Quarterly Report, the Company issued and sold 14,358,057 shares of its common stock under the HCW ATM Agreement at a weighted average price of $ 0.14 per share for net proceeds of approximately $ 1.9 million. Reverse Stock Split At a special meeting of stockholders held on August 4, 2022, the Company’s stockholders approved an amendment to the Company’s amended and restated certificate of incorporation, as amended, to, at the discretion of the Company’s board of directors, effect a reverse stock split with respect to its issued and outstanding Common Stock, par value $ 0.001 per share, including any Common Stock held by the Company as treasury shares, at any time prior to December 31, 2022, at a ratio of 1-for-10 to 1-for-100 (the “Range”). The Range and timing of the reverse stock split will be determined by the Company’s board of directors without further approval or authorization of the Company’s stockholders and included in a public announcement once determined. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The Company’s unaudited interim condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted accounting principles as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates ("ASU") of the Financial Accounting Standards Board (“FASB”). Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted from this report, as is permitted by such rules and regulations. Accordingly, these financial statements should be read in conjunction with the audited financial statements as of and for the year ended December 31, 2021 and notes thereto, included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC on March 31, 2022. The unaudited interim consolidated financial statements have been prepared on the same basis as the audited financial statements. In the opinion of the Company’s management, the accompanying unaudited interim condensed consolidated financial statements contain all adjustments which are necessary to present fairly the Company’s financial position as of June 30, 2022, the results of its operations and cash flows for the three and six months ended June 30, 2022 and June 30, 2021 and cash flows for the six months ended June 30, 2022 and 2021. Such adjustments are of a normal and recurring nature. The results for the three and six months ended June 30, 2022 are not necessarily indicative of the results for the year ending December 31, 2022 or for any future period. Principles of Consolidation The consolidated financial statements include the accounts of Allena Pharmaceuticals, Inc. and its wholly owned subsidiaries Allena Pharmaceuticals Security Corporation (“Security Corporation”), which was incorporated in December 2014 , and Allena Pharmaceuticals Ireland Limited, which was incorporated in March 2017 . All intercompany transactions and balances have been eliminated. Fair Value of Financial Instruments Fair value is defined as the price that would be received upon sale of an asset or paid to transfer a liability between market participants at measurement dates. ASC Topic 820, Fair Value Measurement (“ASC 820”), establishes a three-level valuation hierarchy for instruments measured at fair value. The hierarchy is based on the transparency of inputs to the valuation of an asset or liability as of the measurement date. The hierarchy defines three levels of valuation inputs, of which the first two are considered observable and the last is considered unobservable: Level 1 inputs: Quoted prices in active markets for identical assets or liabilities. Level 2 inputs: Inputs other than quoted prices included within Level 1 that are either directly or indirectly observable, such as quoted market prices, interest rates and yield curves. Level 3 inputs: Unobservable inputs developed using estimates or assumptions developed by the Company, which reflect those that a market participant would use in pricing the asset or liability. To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. The remainder of the Company’s significant accounting policies are described in the Annual Report filed on Form 10-K for the year ended December 31, 2021 that was filed with the United States Securities and Exchange Commission on March 31, 2022. Warrants The Company accounts for issued warrants either as a liability or equity in accordance with ASC 480-10, Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity (“ASC 480-10”) or ASC 815-40, Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company’s Own Stock (“ASC 815-40”). Under ASC 480-10, warrants are considered a liability if they are mandatorily redeemable and they require settlement in cash, other assets, or a variable number of shares. If warrants do not meet liability classification under ASC 480-10, the Company considers the requirements of ASC 815-40 to determine whether the warrants should be classified as a liability or as equity. Under ASC 815-40, contracts that may require settlement for cash are liabilities, regardless of the probability of the occurrence of the triggering event. If warrants do not require liability classification under ASC 815-40, in order to conclude warrants should be classified as equity, the Company assesses whether the warrants are indexed to its common stock and whether the warrants are classified as equity under ASC 815-40 or other applicable GAAP standard. Liability-classified warrants are measured at fair value on the issuance date and at the end of each reporting period. Any change in the fair value of the warrants after the issuance date is recorded in the consolidated statements of operations as a gain or loss. Equity-classified warrants are accounted for at fair value on the issuance date with no changes in fair value recognized after the issuance date. Recently Adopted Accounting Pronouncements In 2020, the FASB issued ASU 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) , which simplifies the accounting for convertible debt and convertible preferred stock by removing the requirements to separately present certain conversion features in equity. In addition, the amendments in the ASU also simplify the guidance in ASC 815-40, Derivatives and Hedging: Contracts in Entity’s Own Equity, by removing certain criteria that must be satisfied in order to classify a contract as equity, which is expected to decrease the number of freestanding instruments and embedded derivatives accounted for as assets or liabilities. Finally, the amendments revise the guidance on calculating earnings per share, requiring use of the if-converted method for all convertible instruments and rescinding an entity’s ability to rebut the presumption of share settlement for instruments that may be settled in cash or other assets. The Company adopted ASU 2020-06 on January 1, 2022 . The adoption of ASU 2020-06 did not have a material impact on the Company's condensed consolidated financial statements. Recently Issued Accounting Pronouncements In 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”), which requires entities to record expected credit losses for certain financial instruments, including trade receivables, as an allowance that reflects the entity's current estimate of credit losses expected to be incurred. For available-for-sale debt securities in unrealized loss positions, ASU 2016-13 requires allowances to be recorded instead of reducing the amortized cost of the investment. ASU 2016-13 is effective for smaller reporting companies on January 1, 2023. Early adoption is permitted. The Company does not expect that the adoption of ASU 2016-13 will have a material impact on its condensed consolidated financial statements. |
Net Loss per Share
Net Loss per Share | 6 Months Ended |
Jun. 30, 2022 | |
Earnings Per Share [Abstract] | |
Net Loss per Share | 3. Net Loss per Share Basic net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding for the period, without consideration for potentially dilutive securities. The Company has computed diluted net loss per common share after giving consideration to all potentially dilutive common shares, including options to purchase common stock, restricted stock units, common stock issuable upon conversion of outstanding debt and warrants to purchase common stock, outstanding during the period determined using the treasury-stock and if-converted methods, except where the effect of including such securities would be antidilutive. Because the Company has reported net losses since inception, these potential common shares have been anti-dilutive and basic and diluted loss per share have been the same. Basic and diluted net loss per share attributable to common stockholders was calculated as follows (in thousands, except share and per share data): Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Numerator: Net loss $ ( 8,435 ) $ ( 13,972 ) $ ( 20,248 ) $ ( 25,608 ) Net loss attributable to common stockholders $ ( 8,435 ) $ ( 13,972 ) $ ( 20,248 ) $ ( 25,608 ) Denominator: Weighted-average common shares—basic and diluted 100,623,730 57,932,389 95,034,212 56,484,811 Net loss per share attributable to common $ ( 0.08 ) $ ( 0.24 ) $ ( 0.21 ) $ ( 0.45 ) The following table sets forth the potentially dilutive securities that have been excluded from the calculation of diluted net loss per share because to include them would be anti-dilutive (in common stock equivalent shares): Six Months Ended June 30, 2022 2021 Stock options 5,435,949 7,091,757 Restricted stock units 2,093,500 372,166 Warrants 34,383,048 9,040 Common stock issuable upon conversion of outstanding debt 1,219,512 2,439,024 Total 43,132,009 9,911,987 |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 4. Fair Value Measurements The following tables present information about the Company’s financial assets and liabilities that have been measured at fair value at June 30, 2022 and December 31, 2021, and indicates the fair value hierarchy of the valuation inputs utilized to determine such fair value (in thousands): Description June 30, Quoted Significant Significant Assets: Money market funds, included in cash and cash equivalents $ 5,589 $ 5,589 $ — $ — Total assets $ 5,589 $ 5,589 $ — $ — Liabilities: Warrant liability $ 3,645 $ — $ — $ 3,645 Total liabilities $ 3,645 $ — $ — $ 3,645 Description December 31, Quoted Significant Significant Assets: Money market funds, included in cash and cash equivalents $ 16,523 $ 16,523 $ — $ — Total assets $ 16,523 $ 16,523 $ — $ — At June 30, 2022 and December 31, 2021, all of the Company’s cash equivalents were comprised of money market funds. There were no changes to the valuation methods during the six months ended June 30, 2022 and year ended December 31, 2021. There were no transfers within the fair value hierarchy during the six months ended June 30, 2022 and the year ended December 31, 2021. The carrying amounts reflected in the consolidated balance sheets for cash and cash equivalents, prepaid expenses and other current assets, accounts payable and accrued expenses approximate their fair values. Assumptions Used in Determining Fair Value of Warrants The Company issued the 2022 Common Warrants and the HCW Warrants to purchase an aggregate of up to 23,695,136 shares of common stock in connection with a registered direct financing on May 4, 2022 (see Note 8). The Company concluded that the warrants are not indexed to its own stock and therefore the 2022 Common Warrants and the HCW Warrants are being accounted for as liabilities. The Company recorded the fair value of the warrants upon issuance using the Black-Scholes valuation model and is required to revalue the warrants at each reporting date with any changes in fair value recorded on the statement of operations. The valuation of the warrants is considered under Level 3 of the fair value hierarchy and influenced by the fair value of the underlying common stock of the Company. A summary of the Black Scholes pricing model assumptions used to record the fair value of the warrants is as follows: June 30, 2022 May 4, 2022 Stock price $ 0.19 $ 0.14 Risk-free interest rate 3.01 % 2.93 % Expected dividend yield —% —% Expected term (in years) 4.9 - 5.4 5.0 - 5.5 Expected volatility 106 % 105 % Changes in Level 3 Liabilities Measured at Fair Value on a Recurring Basis The following table reflects the change in the Company’s Level 3 Warrant liability for the six months ended June 30, 2022 (in thousands): Fair value of warrant liability as of the beginning of the period $ — Issuance of warrants 2,622 Change in fair value 1,023 Fair value of warrant liability as of the end of the period $ 3,645 |
Accrued Expenses
Accrued Expenses | 6 Months Ended |
Jun. 30, 2022 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | 5. Accrued Expenses Accrued expenses consist of the following (in thousands): June 30, December 31, Payroll and employee-related expenses $ 295 $ 371 Third-party research and development expenses 2,260 3,195 Professional fees 184 677 Loan interest 112 227 Other 19 10 Total accrued expenses $ 2,870 $ 4,480 |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 6. Commitments and Contingencies The Company is a party to an operating lease for approximately 11,691 square feet of laboratory and office space in Sudbury, MA (Sudbury Lease). The Sudbury Lease expires on February 28, 2026 . The Company has a one-time option to cancel the lease effective February 28, 2023 for any reason or no reason at all . Annualized base rent for the Sudbury lease is approximately $ 0.3 million. Maturities of the Company’s operating lease liabilities in accordance with ASC 842 as of June 30, 2022 are as follows (in thousands): Remainder of 2022 $ 158 2023 231 Total maturities 389 Less: Amount representing interest ( 9 ) Present value of operating lease liabilities $ 380 Lease costs included in the Company’s condensed consolidated statements of operations and comprehensive loss for each of the three and six months ended June 30, 2022 and 2021 were $ 0.1 million and $ 0.2 million, respectively. The Company’s operating leases had a weighted average remaining lease term of nine months and a weighted average discount rate of 5.5 % at June 30, 2022. During the reporting period, the Company was also a party to an operating lease for approximately 6,055 square feet of office space in Newton, MA (Newton Lease). Pursuant to its terms, the Newton Lease terminates on the last day of the month following the month either party notifies the other that the term of the lease shall end . The annualized base rent for the Newton Lease is approximately $ 0.3 million. Due to the short nature of the minimum lease term of the Newton Lease, the Newton Lease was not considered as an operating lease liability in accordance with ASC 842 as of June 30, 2022 . On June 15, 2022, the Company delivered to the lessor written notice of termination of the Newton Lease effective July 31, 2022. |
Convertible Debt Agreement
Convertible Debt Agreement | 6 Months Ended |
Jun. 30, 2022 | |
Debt Disclosure [Abstract] | |
Convertible Debt Agreement | 7. Convertible Debt Agreement On September 29, 2020, the Company entered into the Pontifax Agreement, providing up to $ 25.0 million of borrowings through three facilities of a term loan. An initial loan (“Initial Loan”) of $ 10.0 million was advanced on September 29, 2020 (“Closing Date”). An additional $ 5.0 million credit line (“Credit Line”) was available to the Company for withdrawal for a period of 12 months from the Closing Date. The Company paid a fee of 1.0 % per annum to Pontifax for the daily average amount not withdrawn under the Credit Line. A third installment loan (“Third Installment Loan”) of $ 10.0 million was conditioned upon achievement of one of the following milestones by no later than 15 months from the Closing Date: (i) the Company receives non-contingent, non-refundable gross proceeds from one or more equity financings and/or strategic partnerships, in each case consummated following the Closing Date, in the aggregate amount of at least $ 15.0 million for all such equity financings and strategic partnerships or (ii) the 65th patient has been enrolled in the URIROX-2 trial. During the three months ended December 31, 2020, the additional $ 10 million under the Third Installment Loan became available to the Company when the milestone of at least $ 15 million of gross proceeds from equity financings was achieved. The availability to withdraw amounts available under the Credit Line expired unused on September 29, 2021 and the availability to withdraw amounts available under the Third Installment Loan expired unused on December 29, 2021 . Amounts outstanding under the Pontifax Agreement have a fixed interest rate of 9.0 % per annum. The Pontifax Agreement has a term of 48 months and an interest only period of 24 months . Upon the expiration of the interest only period on September 29, 2022 , amounts borrowed will be repaid over eight equal quarterly payments of principal and interest. At its option, the Company may prepay all or part of the outstanding borrowings at any time without any prepayment premium or penalty. The Pontifax Agreement contains negative covenants restricting the Company’s activities, including limitations on dispositions, mergers or acquisitions, incurring indebtedness or liens, paying dividends or making investments and certain other business transactions. There are no financial covenants associated with the Pontifax Agreement. The obligations under the Pontifax Agreement are subject to acceleration upon the occurrence of specified events of default, including a material adverse change in the Company’s business, operations or financial or other condition. Pontifax, at its option, has the right to convert at any time any portion of the then outstanding borrowings and all accrued but unpaid interest into shares of the Company’s common stock, at the applicable conversion price. The conversion price for borrowings outstanding under the Pontifax Agreement is fixed at $ 4.10 per share. If the Company consummates a stock split, stock combination, reclassification, payment of stock dividend, recapitalization or other similar transaction (each a “Stock Event”), then the applicable conversion price will be proportionately increased or decreased as necessary to reflect the proportionate change in shares of the Company’s common stock issued and outstanding as a result of such Stock Event. The Company has the right to convert at any time any portion of the then outstanding borrowings and all accrued but unpaid interest into shares of the Company’s common stock, at the applicable conversion price, subject to the fulfillment of both of the following conditions: (i) during a period of 30 consecutive trading days prior to the date on which the Company provides notice of the exercise of its conversion right, the closing price of the Company’s common stock was higher than 1.4 times the applicable conversion price of the term loans on at least 20 trading days, including on the trading day preceding the date on which the Company provides notice of the exercise of its conversion right, (ii) the number of shares of common stock issuable upon conversion by the Company shall not exceed the average weekly number of shares of the Company’s common stock traded on the stock market for the four weeks immediately preceding the date on which the Company provides notice of the exercise of its conversion right. The shares of the Company’s common stock issued upon conversion will be free of any restrictions and the Company is required to hold at all times a sufficient number of authorized, unreserved and unissued shares of its common stock required to settle any such conversion. The Company has reserved 1,219,512 shares of its common stock for conversion of the outstanding debt balance as of June 30, 2022. The Company evaluated the Pontifax Agreement for embedded features that require bifurcation, noting certain features were required to be bifurcated, but were concluded to be de minimis in value at June 30, 2022 and December 31, 2021. The Company determined the conversion feature was not required to be accounted for separately. The Company concluded that the embedded conversion option is not subject to separate accounting pursuant to either the cash conversion guidance or the beneficial conversion feature guidance. As part of the strategic process initiated in January 2022, the Company has held discussions with Pontifax regarding repayment of amounts outstanding under the Pontifax Agreement. Taking into consideration the available cash and cash equivalents at December 31, 2021 along with the termination of its reloxaliase program in March 2022 and its inability to raise sufficient capital to sustain its operations as of the date of this Quarterly Report, the Company determined that, consistent with the determination at December 31, 2021, it was appropriate to classify the full amount outstanding under the Pontifax Agreement as a current liability as of June 30, 2022 given the subjective acceleration of payment under the material adverse change clause. During the first quarter of 2022, the Company made voluntary repayments of principal totaling $ 5.0 million. The Company made an additional voluntary repayment of principal of $ 0.5 million in August 2022 The minimum aggregate future loan and interest payments at June 30, 2022 are as follows (in thousands): Years Ending December 31, 2022 $ 803 2023 2,760 2024 2,070 Total minimum payments $ 5,633 Less: Amount representing interest ( 633 ) Less; Discount ( 96 ) Less: Current portion ( 4,904 ) Loan payable, net of current portion $ — |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2022 | |
Equity [Abstract] | |
Stockholders' Equity | 8. Stockholders’ Equity On May 3, 2022, the Company entered into a securities purchase agreement with an investor, pursuant to which the Company agreed to issue, in a registered direct offering, an aggregate of 2,872.1376 shares of Preferred Stock (split evenly between the Series D Convertible Preferred Stock, and Series E Convertible Preferred Stock). The Company received net proceeds of approximately $ 2.3 million from the issuance and sale of the Preferred Stock, after deducting offering expenses and placement agent fees. The shares of Preferred Stock have a stated value of $ 1,000 per share and are convertible, following the date of the issuance thereof, into an aggregate of 8,975,430 shares of common stock of the Company upon the conversion of the Series D Preferred Stock and into an aggregate of 8,975,430 shares of common stock of the Company upon the conversion of the Series E Preferred Stock, in each case, at a conversion price of $ 0.16 per share. HCW was the exclusive placement agent for this offering. On May 5, 2022, the Preferred Stock investor converted all of its Series D Preferred Stock into 8,975,430 shares of common stock, and on May 9, 2022, the Preferred Stock investor converted all of its Series E Preferred Stock into 8,975,430 shares of common stock. In a concurrent private placement, the Company also issued to the Preferred Stock investor the 2022 Common Warrants to purchase up to an aggregate of 22,438,575 shares of the Company’s common stock, at an exercise price of $ 0.1694 per share. The 2022 Common Warrants will become exercisable six months after the date of issuance, and will have a term of five years from the initial exercise date. The Company also issued to designees of HCW, in a concurrent private placement, the HCW Warrants to purchase up to 1,256,561 shares of Common Stock. The HCW Warrants are exercisable for $ 0.20 per share and will be exercisable six months after the date of issuance and have a term of five years from the commencement of sales pursuant to the registered direct offering. On July 16, 2021, the Company completed a registered direct offering, in which the Company issued and sold 17,416,096 shares of its common stock, pre-funded warrants ("2021 Pre-funded Warrants") to purchase up to an aggregate of 3,941,648 shares of its common stock in lieu of shares of common stock, and warrants ("2021 Common Warrants") to purchase up to 10,678,872 shares of the Company’s common stock through a securities purchase agreement with several healthcare-focused institutional and accredited investors. The combined price of each share of common stock and accompanying 2021 Common Warrant to purchase one-half of a share of common stock was $ 1.311 per share. The purchase price of each 2021 Pre-funded Warrant was $ 1.301 , which was the combined purchase price per share of common stock and accompanying 2021 Common Warrant to purchase one-half of a share of common stock, minus $ 0.01 . Gross proceeds of the transaction were $ 28.0 million. As a result of the registered direct offering, the Company received approximately $ 25.4 million after deducting offering costs. Each 2021 Common Warrant is exercisable for one share of the Company’s common stock at an exercise price of $ 1.25 per share. The 2021 Common Warrants are immediately exercisable and expire on July 16, 2026 . Each Pre-funded Warrant is exercisable for one share of common stock at an exercise price of $ 0.01 per share. All of the 2021 Pre-funded Warrants were exercised on July 16, 2021 . During the first quarter of 2021, the Company issued and sold 6,058,318 shares of its common stock under an At-the Market Equity Offering Sales Agreement with Cowen and Company, LLC (Cowen ATM Agreement) at a weighted average price of $ 1.99 per share for net proceeds of $ 11.7 million. The Company entered into an At Market Issuance Sales Agreement with B. Riley Securities, Inc. (“B. Riley ATM Agreement”) on March 29, 2021. During the year ended December 31, 2021, the Company issued and sold a total of 4,081,338 shares of its common stock under the B. Riley ATM Agreement at a weighted average price of $ 1.11 per share for net proceeds of approximately $ 4.2 million. The Cowen ATM Agreement was terminated at the time the Company entered into the B. Riley ATM Agreement. The Company entered into another At Market Issuance Sales Agreement with B. Riley Securities, Inc. (“Updated B. Riley ATM Agreement”) on December 23, 2021. During the first quarter of 2022, the Company issued and sold 6,804,888 shares of its common stock under the Updated B. Riley ATM Agreement at a weighted average price of $ 0.62 per share for net proceeds of $ 3.9 million. The B. Riley ATM Agreement was terminated at the time the Company entered into the Updated B. Riley Agreement. The Company entered into the HCW ATM Agreement on July 8, 2022. Since that time and through the filing date of this Quarterly Report, the Company issued and sold 14,358,057 shares of its common stock under the HCW ATM Agreement at a weighted average price of $ 0.14 per share for net proceeds of approximately $ 1.9 million. The Updated B. Riley ATM Agreement was terminated at the time the Company entered into the HCW ATM Agreement. Common Stock The holders of common stock are entitled to one vote for each share held . Common stockholders are not entitled to receive dividends, unless declared by the Board of Directors. The Company has reserved for future issuances the following shares of common stock as of June 30, 2022 and December 31, 2021: June 30, December 31, Stock options and restricted stock units 11,691,089 8,372,313 Warrants 34,383,048 10,687,912 Common stock issuable upon conversion of outstanding debt 1,219,512 2,439,024 Employee stock purchase plan 306,527 306,527 Total 47,600,176 21,805,776 Warrants At June 30, 2022 the Company had 34,383,048 warrants outstanding for the purchase of shares of common stock at a weighted average exercise price of $ 0.51 . At December 31, 2021 , the Company had 10,687,912 warrants outstanding for the purchase of shares of common stock at a weighted average exercise price of $ 1.26 . 22,438,575 warrants with an exercise price of $ 0.1694 and 1,256,561 warrants with an exercise price of $ 0.20 expire May 3, 2027 . 10,678,872 w arrants with an exercise price of $ 1.25 expire on July 16, 2026 . 9,040 warrants with an exercise price of $ 11.06 expire on May 1, 2026 . Preferred Stock On July 12, 2022, the Company entered into a Subscription and Investment Representation Agreement (the “Subscription Agreement”) with a single accredited investor (the “Subscriber”), pursuant to which the Company agreed to issue and sell 100 shares of the Company’s Series F Non-Convertible Preferred Stock, par value $ 0.001 per share (the “Series F Non-Convertible Preferred Stock”), to the Subscriber for $ 100.00 in cash. The sale was completed and settled on July 12, 2022. The Subscription Agreement contains customary representations and warranties and certain indemnification rights and obligations of the parties. The Series F Non-Convertible Preferred Stock is not convertible into shares of the Company’s common stock or any other class or series of stock of the Company. In the event of any liquidation, dissolution or winding-up of the Company, whether voluntary or involuntary, the holders of Series F Non-Convertible Preferred Stock shall be entitled to receive, in priority to any distributions to the holders of Common Stock, out of the assets, whether capital or surplus, of the Company an amount equal to $ 0.01 per share, or $ 1.00 in the aggregate. The holder of the Series F Non-Convertible Preferred Stock will not be entitled to receive dividends of any kind. |
Stock Incentive Plan
Stock Incentive Plan | 6 Months Ended |
Jun. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Stock Incentive Plans | 9. Stock Incentive Plans On October 31, 2017 , the Company adopted the 2017 Stock Option and Incentive Plan (“2017 Plan”). Upon the adoption of the 2017 Plan, no further grants would be made under the 2011 Stock Incentive Plan (“2011 Plan”). The 2017 Plan initially provided for the grant of awards for 2,038,021 shares of common stock. In addition to the shares available for grant under the 2017 Plan, shares underlying any awards outstanding under the 2011 Plan as of October 31, 2017 that are cancelled, forfeited or otherwise terminated without being exercised will be available for future grant under the 2017 Plan. The 2017 Plan also provides that an additional number of shares will automatically be added to the shares authorized for issuance under the 2017 Plan on January 1 of each year. The number of shares added each year will be equal to the lesser of: (i) 4 % of the outstanding shares on the immediately preceding December 31 or (ii) such amount as determined by the Compensation Committee of the registrant’s Board of Directors. On January 1, 2020, 2021 and 2022, the shares available for grant under the 2017 Plan were automatically increased by 989,400 , 2,032,854 and 3,318,776 shares, respectively. All of the Company’s employees, officers, directors, consultants and advisors are eligible to be granted options, restricted stock units (“RSUs”), and other share-based awards under the terms of the 2017 Plan. As of June 30, 2022 , 3,016,640 shares of common stock were available for future grant under the 2017 Plan. On January 22, 2021, the Company adopted the 2021 Inducement Equity Plan (“2021 Plan”). The 2021 Plan provides for the grant of awards for 1,600,000 shares of common stock. The purpose of the 2021 plan is to enable the Company to grant equity awards to induce highly qualified prospective officers and employees who are not currently employed by the Company to accept employment and provide them with an equity interest in the Company. The Company is utilizing the 2021 Plan for awards the Company may make without stockholder approval as an inducement pursuant to Rule 5635(c)(4) of the Marketplace Rules of the Nasdaq Stock Market, Inc. As of June 30, 2022 , 1,145,000 shares of common stock were available for future grant under the 2021 Plan. All stock option grants are nonstatutory stock options except option grants to employees (including officers and directors) intended to qualify as incentive stock options under the Internal Revenue Code of 1986, as amended. Incentive stock options may not be granted at less than the fair market value of the Company’s common stock on the date of grant, as determined in good faith by the Board of Directors at its sole discretion. Nonqualified stock options may be granted at an exercise price established by the Board of Directors at its sole discretion (which has not been less than fair market value on the date of grant) and the vesting periods may vary. Vesting periods are generally four years and are determined by the Board of Directors or a delegated subcommittee. Stock options become exercisable as they vest. Options granted under the 2011 Plan, 2017 Plan and 2021 Plan expire no more than 10 years from the date of grant. Stock-based compensation expense included in the Company’s statements of operations and comprehensive loss is as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Research and development $ 135 $ 303 $ 305 $ 550 General and administrative 425 657 872 1,277 Total $ 560 $ 960 $ 1,177 $ 1,827 The fair value of each stock option granted to employees and directors during the three and six months ended June 30, 2021 was estimated on the date of grant using the Black-Scholes option-pricing model, with the following range of assumptions: Three Months Ended June 30, 2021 Six Months Ended June 30, 2021 Risk-free interest rate 0.9 %- 1.4 % 0.4 %- 1.4 % Expected dividend yield —% —% Expected term (in years) 5.4 - 7.0 5.0 - 7.0 Expected volatility 93 %- 94 % 93 %- 94 % The Company did no t grant any stock options during the three and six months ended June 30, 2022. A summary of the stock option activity under the 2011, 2017 and 2021 Plans during the six months ended June 30, 2022 is as follows: Shares Weighted- Weighted- Aggregate Outstanding at December 31, 2021 6,765,837 $ 2.81 7.6 $ 3 Granted — — Exercised — — Forfeited ( 1,316,712 ) 2.54 Expired ( 13,176 ) 0.42 Outstanding at June 30, 2022 5,435,949 2.88 7.0 $ — Exercisable at June 30, 2022 3,417,270 $ 3.31 6.2 $ — As of June 30, 2022 , total unrecognized stock-based compensation expense relating to unvested stock options was $ 3.1 million. This amount is expected to be recognized over a weighted-average period of 2.2 years. Restricted Stock Units (RSUs) On February 1, 2022, the Company awarded 2,998,500 RSUs to employees of the Company as part of the Retention Plan. The RSUs vest over a three-year period ratably on July 15th and January 15th of each year following grant date. The RSUs are generally forfeited if the employment relationship terminates with the Company prior to vesting. Shares Weighted-Average Nonvested at December 31, 2021 — $ — Granted 2,998,500 0.40 Vested — — Forfeited ( 905,000 ) 0.40 Nonvested at June 30, 2022 2,093,500 $ 0.40 As of June 30, 2022 , the total remaining unrecognized compensation cost related to all nonvested RSUs amounted to $ 0.7 million. This amount is expected to be recognized over a weighted-average period of 2.5 years . |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The Company’s unaudited interim condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted accounting principles as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates ("ASU") of the Financial Accounting Standards Board (“FASB”). Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted from this report, as is permitted by such rules and regulations. Accordingly, these financial statements should be read in conjunction with the audited financial statements as of and for the year ended December 31, 2021 and notes thereto, included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC on March 31, 2022. The unaudited interim consolidated financial statements have been prepared on the same basis as the audited financial statements. In the opinion of the Company’s management, the accompanying unaudited interim condensed consolidated financial statements contain all adjustments which are necessary to present fairly the Company’s financial position as of June 30, 2022, the results of its operations and cash flows for the three and six months ended June 30, 2022 and June 30, 2021 and cash flows for the six months ended June 30, 2022 and 2021. Such adjustments are of a normal and recurring nature. The results for the three and six months ended June 30, 2022 are not necessarily indicative of the results for the year ending December 31, 2022 or for any future period. |
Principles of Consolidation | Principles of Consolidation The consolidated financial statements include the accounts of Allena Pharmaceuticals, Inc. and its wholly owned subsidiaries Allena Pharmaceuticals Security Corporation (“Security Corporation”), which was incorporated in December 2014 , and Allena Pharmaceuticals Ireland Limited, which was incorporated in March 2017 . All intercompany transactions and balances have been eliminated. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments Fair value is defined as the price that would be received upon sale of an asset or paid to transfer a liability between market participants at measurement dates. ASC Topic 820, Fair Value Measurement (“ASC 820”), establishes a three-level valuation hierarchy for instruments measured at fair value. The hierarchy is based on the transparency of inputs to the valuation of an asset or liability as of the measurement date. The hierarchy defines three levels of valuation inputs, of which the first two are considered observable and the last is considered unobservable: Level 1 inputs: Quoted prices in active markets for identical assets or liabilities. Level 2 inputs: Inputs other than quoted prices included within Level 1 that are either directly or indirectly observable, such as quoted market prices, interest rates and yield curves. Level 3 inputs: Unobservable inputs developed using estimates or assumptions developed by the Company, which reflect those that a market participant would use in pricing the asset or liability. To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. The remainder of the Company’s significant accounting policies are described in the Annual Report filed on Form 10-K for the year ended December 31, 2021 that was filed with the United States Securities and Exchange Commission on March 31, 2022. |
Warrants | Warrants The Company accounts for issued warrants either as a liability or equity in accordance with ASC 480-10, Accounting for Certain Financial Instruments with Characteristics of both Liabilities and Equity (“ASC 480-10”) or ASC 815-40, Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company’s Own Stock (“ASC 815-40”). Under ASC 480-10, warrants are considered a liability if they are mandatorily redeemable and they require settlement in cash, other assets, or a variable number of shares. If warrants do not meet liability classification under ASC 480-10, the Company considers the requirements of ASC 815-40 to determine whether the warrants should be classified as a liability or as equity. Under ASC 815-40, contracts that may require settlement for cash are liabilities, regardless of the probability of the occurrence of the triggering event. If warrants do not require liability classification under ASC 815-40, in order to conclude warrants should be classified as equity, the Company assesses whether the warrants are indexed to its common stock and whether the warrants are classified as equity under ASC 815-40 or other applicable GAAP standard. Liability-classified warrants are measured at fair value on the issuance date and at the end of each reporting period. Any change in the fair value of the warrants after the issuance date is recorded in the consolidated statements of operations as a gain or loss. Equity-classified warrants are accounted for at fair value on the issuance date with no changes in fair value recognized after the issuance date. |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements In 2020, the FASB issued ASU 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) , which simplifies the accounting for convertible debt and convertible preferred stock by removing the requirements to separately present certain conversion features in equity. In addition, the amendments in the ASU also simplify the guidance in ASC 815-40, Derivatives and Hedging: Contracts in Entity’s Own Equity, by removing certain criteria that must be satisfied in order to classify a contract as equity, which is expected to decrease the number of freestanding instruments and embedded derivatives accounted for as assets or liabilities. Finally, the amendments revise the guidance on calculating earnings per share, requiring use of the if-converted method for all convertible instruments and rescinding an entity’s ability to rebut the presumption of share settlement for instruments that may be settled in cash or other assets. The Company adopted ASU 2020-06 on January 1, 2022 . The adoption of ASU 2020-06 did not have a material impact on the Company's condensed consolidated financial statements. |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements In 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”), which requires entities to record expected credit losses for certain financial instruments, including trade receivables, as an allowance that reflects the entity's current estimate of credit losses expected to be incurred. For available-for-sale debt securities in unrealized loss positions, ASU 2016-13 requires allowances to be recorded instead of reducing the amortized cost of the investment. ASU 2016-13 is effective for smaller reporting companies on January 1, 2023. Early adoption is permitted. The Company does not expect that the adoption of ASU 2016-13 will have a material impact on its condensed consolidated financial statements. |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Earnings Per Share [Abstract] | |
Summary of Basic and Diluted Net Loss per Share Attributable to Common Stockholders | Basic and diluted net loss per share attributable to common stockholders was calculated as follows (in thousands, except share and per share data): Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Numerator: Net loss $ ( 8,435 ) $ ( 13,972 ) $ ( 20,248 ) $ ( 25,608 ) Net loss attributable to common stockholders $ ( 8,435 ) $ ( 13,972 ) $ ( 20,248 ) $ ( 25,608 ) Denominator: Weighted-average common shares—basic and diluted 100,623,730 57,932,389 95,034,212 56,484,811 Net loss per share attributable to common $ ( 0.08 ) $ ( 0.24 ) $ ( 0.21 ) $ ( 0.45 ) |
Summary of Anti-dilutive Securities Excluded from Calculation of Diluted Net Loss per Share | The following table sets forth the potentially dilutive securities that have been excluded from the calculation of diluted net loss per share because to include them would be anti-dilutive (in common stock equivalent shares): Six Months Ended June 30, 2022 2021 Stock options 5,435,949 7,091,757 Restricted stock units 2,093,500 372,166 Warrants 34,383,048 9,040 Common stock issuable upon conversion of outstanding debt 1,219,512 2,439,024 Total 43,132,009 9,911,987 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Summary of Financial Assets and Liabilities Measured at Fair Value | The following tables present information about the Company’s financial assets and liabilities that have been measured at fair value at June 30, 2022 and December 31, 2021, and indicates the fair value hierarchy of the valuation inputs utilized to determine such fair value (in thousands): Description June 30, Quoted Significant Significant Assets: Money market funds, included in cash and cash equivalents $ 5,589 $ 5,589 $ — $ — Total assets $ 5,589 $ 5,589 $ — $ — Liabilities: Warrant liability $ 3,645 $ — $ — $ 3,645 Total liabilities $ 3,645 $ — $ — $ 3,645 Description December 31, Quoted Significant Significant Assets: Money market funds, included in cash and cash equivalents $ 16,523 $ 16,523 $ — $ — Total assets $ 16,523 $ 16,523 $ — $ — |
Summary of Black Scholes Pricing Model Assumptions Used to Record Fair Value of Warrants | A summary of the Black Scholes pricing model assumptions used to record the fair value of the warrants is as follows: June 30, 2022 May 4, 2022 Stock price $ 0.19 $ 0.14 Risk-free interest rate 3.01 % 2.93 % Expected dividend yield —% —% Expected term (in years) 4.9 - 5.4 5.0 - 5.5 Expected volatility 106 % 105 % |
Summary of Change in Level 3 Warrant Liability | The following table reflects the change in the Company’s Level 3 Warrant liability for the six months ended June 30, 2022 (in thousands): Fair value of warrant liability as of the beginning of the period $ — Issuance of warrants 2,622 Change in fair value 1,023 Fair value of warrant liability as of the end of the period $ 3,645 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consist of the following (in thousands): June 30, December 31, Payroll and employee-related expenses $ 295 $ 371 Third-party research and development expenses 2,260 3,195 Professional fees 184 677 Loan interest 112 227 Other 19 10 Total accrued expenses $ 2,870 $ 4,480 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
ASC 842 | |
Operating Leased Assets [Line Items] | |
Schedule of Maturities of Operating Lease Liabilities | Maturities of the Company’s operating lease liabilities in accordance with ASC 842 as of June 30, 2022 are as follows (in thousands): Remainder of 2022 $ 158 2023 231 Total maturities 389 Less: Amount representing interest ( 9 ) Present value of operating lease liabilities $ 380 |
Convertible Debt Agreement (Tab
Convertible Debt Agreement (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Debt Disclosure [Abstract] | |
Summary of Minimum Aggregate Future Loan and Interest Payments | The minimum aggregate future loan and interest payments at June 30, 2022 are as follows (in thousands): Years Ending December 31, 2022 $ 803 2023 2,760 2024 2,070 Total minimum payments $ 5,633 Less: Amount representing interest ( 633 ) Less; Discount ( 96 ) Less: Current portion ( 4,904 ) Loan payable, net of current portion $ — |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Equity [Abstract] | |
Summary of Shares of Common Stock Reserved | The Company has reserved for future issuances the following shares of common stock as of June 30, 2022 and December 31, 2021: June 30, December 31, Stock options and restricted stock units 11,691,089 8,372,313 Warrants 34,383,048 10,687,912 Common stock issuable upon conversion of outstanding debt 1,219,512 2,439,024 Employee stock purchase plan 306,527 306,527 Total 47,600,176 21,805,776 |
Stock Incentive Plans (Tables)
Stock Incentive Plans (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Summary of Stock-based Compensation Expense | Stock-based compensation expense included in the Company’s statements of operations and comprehensive loss is as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Research and development $ 135 $ 303 $ 305 $ 550 General and administrative 425 657 872 1,277 Total $ 560 $ 960 $ 1,177 $ 1,827 |
Summary of Stock Option Activity | A summary of the stock option activity under the 2011, 2017 and 2021 Plans during the six months ended June 30, 2022 is as follows: Shares Weighted- Weighted- Aggregate Outstanding at December 31, 2021 6,765,837 $ 2.81 7.6 $ 3 Granted — — Exercised — — Forfeited ( 1,316,712 ) 2.54 Expired ( 13,176 ) 0.42 Outstanding at June 30, 2022 5,435,949 2.88 7.0 $ — Exercisable at June 30, 2022 3,417,270 $ 3.31 6.2 $ — |
Restricted Stock Units (RSUs) | |
Summary of Nonvested RSUs | Shares Weighted-Average Nonvested at December 31, 2021 — $ — Granted 2,998,500 0.40 Vested — — Forfeited ( 905,000 ) 0.40 Nonvested at June 30, 2022 2,093,500 $ 0.40 |
Employees and Directors | |
Schedule of Assumptions Used in Black-Scholes Option Pricing Model to Estimate Fair Value of Stock Options | The fair value of each stock option granted to employees and directors during the three and six months ended June 30, 2021 was estimated on the date of grant using the Black-Scholes option-pricing model, with the following range of assumptions: Three Months Ended June 30, 2021 Six Months Ended June 30, 2021 Risk-free interest rate 0.9 %- 1.4 % 0.4 %- 1.4 % Expected dividend yield —% —% Expected term (in years) 5.4 - 7.0 5.0 - 7.0 Expected volatility 93 %- 94 % 93 %- 94 % |
Nature of Business - Additional
Nature of Business - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||||||||
Jul. 08, 2022 | May 03, 2022 | Jan. 28, 2022 | Jul. 16, 2021 | Aug. 31, 2022 | Mar. 31, 2022 | Mar. 31, 2022 | Jun. 30, 2022 | Jun. 30, 2021 | Aug. 04, 2022 | May 09, 2022 | May 05, 2022 | Dec. 31, 2021 | |
Class of Stock [Line Items] | |||||||||||||
Accumulated deficit | $ (266,700) | $ (246,452) | |||||||||||
Cash and cash equivalents | $ 6,589 | $ 29,988 | |||||||||||
Directors' & Officers' run off insurance amount | $ 6,800 | ||||||||||||
Restructuring charges, number of workforce headcount reduction percentage | 40% | ||||||||||||
Preferred stock issued | 2,872 | 0 | |||||||||||
Preferred stock par value | $ 0.001 | $ 0.001 | |||||||||||
Exercise price of warrants | $ 0.51 | 1.26 | |||||||||||
Net proceeds after deducting estimated offering costs | $ 3,944 | $ 13,464 | |||||||||||
Common stock, par value | $ 0.001 | $ 0.001 | |||||||||||
Loan and Security Agreement | Pontifax | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Voluntary principal repayments | $ 500 | $ 5,000 | |||||||||||
Outstanding principal balance | $ 5,000 | $ 5,000 | $ 4,500 | $ 10,000 | |||||||||
Retention Plan | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Retention agreement received salary adjustment percentage | 6.50% | ||||||||||||
RSUs granted | 2,998,500 | ||||||||||||
Employees retention payment | $ 3,000 | ||||||||||||
Percentage of amount employee to repay for resigns or terminated | 50% | ||||||||||||
Securities Purchase Agreement | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Preferred stock issued | 2,872.1376 | ||||||||||||
Preferred stock par value | $ 1,000 | ||||||||||||
Net proceeds from issuance of preferred stock | $ 2,300 | ||||||||||||
Conversion price | $ 16 | ||||||||||||
Securities Purchase Agreement | Series D Preferred Stock | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Preferred stock par value | $ 0.001 | ||||||||||||
Conversion of preferred stock | 8,975,430 | 8,975,430 | |||||||||||
Securities Purchase Agreement | Series E Preferred Stock | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Preferred stock par value | $ 0.001 | ||||||||||||
Conversion of preferred stock | 8,975,430 | 8,975,430 | |||||||||||
Conversion price | $ 0.16 | ||||||||||||
At Market Issuance Sales Agreement | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Common stock shares issued and sold | 4,081,338 | ||||||||||||
At Market Issuance Sales Agreement | Updated B. Riley ATM Agreement. | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Common stock shares issued and sold | 6,804,888 | ||||||||||||
Weighted average price of common stock shares sold and issued | $ 0.62 | ||||||||||||
Net proceeds after deducting estimated offering costs | $ 3,900 | ||||||||||||
HCW Warrants | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Warrant issued | 1,256,561 | ||||||||||||
Exercise price of warrants | $ 0.20 | ||||||||||||
Warrant term | 5 years | ||||||||||||
2022 Common Warrants | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Warrant issued | 22,438,575 | ||||||||||||
Exercise price of warrants | $ 0.1694 | ||||||||||||
Warrant term | 5 years | ||||||||||||
Subsequent Event | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Common stock, par value | $ 0.001 | ||||||||||||
Subsequent Event | HCW ATM Agreement | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Common stock shares issued and sold | 14,358,057 | ||||||||||||
Weighted average price of common stock shares sold and issued | $ 0.14 | ||||||||||||
Net proceeds after deducting estimated offering costs | $ 1,900 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Details) | 6 Months Ended |
Jun. 30, 2022 | |
ASU 2020-06 | |
Summary Of Significant Accounting Policies [Line Items] | |
Change in Accounting Principle, Accounting Standards Update, Adopted | true |
Change in Accounting Principle, Accounting Standards Update, Adoption Date | Jan. 01, 2022 |
Change in Accounting Principle, Accounting Standards Update, Immaterial Effect | false |
Allena Pharmaceuticals Ireland Limited | |
Summary Of Significant Accounting Policies [Line Items] | |
Entity incorporated date | 2017-03 |
Subsidiaries | |
Summary Of Significant Accounting Policies [Line Items] | |
Entity incorporated date | 2014-12 |
Net Loss per Share - Summary of
Net Loss per Share - Summary of Basic and Diluted Net Loss per Share Attributable to Common Stockholders (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Numerator: | ||||
Net loss | $ (8,435) | $ (13,972) | $ (20,248) | $ (25,608) |
Net loss attributable to common stockholders | $ (8,435) | $ (13,972) | $ (20,248) | $ (25,608) |
Denominator: | ||||
Weighted-average common share outstanding-basic | 100,623,730 | 57,932,389 | 95,034,212 | 56,484,811 |
Weighted-average common share outstanding-diluted | 100,623,730 | 57,932,389 | 95,034,212 | 56,484,811 |
Net loss per share attributable to common stockholders-diluted | $ (0.08) | $ (0.24) | $ (0.21) | $ (0.45) |
Net loss per share attributable to common stockholders-basic | $ (0.08) | $ (0.24) | $ (0.21) | $ (0.45) |
Net Loss per Share - Summary _2
Net Loss per Share - Summary of Anti-dilutive Securities Excluded from Calculation of Diluted Net Loss per Share (Details) - shares | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from the calculation of loss per share | 43,132,009 | 9,911,987 |
Stock Options | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from the calculation of loss per share | 5,435,949 | 7,091,757 |
Restricted Stock Units | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from the calculation of loss per share | 2,093,500 | 372,166 |
Convertible Debt Securities Member | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from the calculation of loss per share | 34,383,048 | 9,040 |
Warrants | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from the calculation of loss per share | 1,219,512 | 2,439,024 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Financial Assets and Liabilities Measured at Fair Value (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Assets: | ||
Total assets | $ 5,589 | $ 16,523 |
Liabilities: | ||
Warrant liability | 3,645 | |
Total liabilities | 3,645 | |
Level 1 | ||
Assets: | ||
Total assets | 5,589 | 16,523 |
Level 3 | ||
Liabilities: | ||
Warrant liability | 3,645 | |
Total liabilities | 3,645 | |
Money market funds, included in cash and cash equivalents | ||
Assets: | ||
Money market funds, included in cash and cash equivalents | 5,589 | 16,523 |
Money market funds, included in cash and cash equivalents | Level 1 | ||
Assets: | ||
Money market funds, included in cash and cash equivalents | $ 5,589 | $ 16,523 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) - USD ($) | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2022 | Dec. 31, 2021 | May 04, 2022 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Change in valuation methods or transfers | $ 0 | $ 0 | |
Transfers within fair value hierarchy | $ 0 | $ 0 | |
2022 Common Warrants and HCW Warrants | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Warrant issued | 23,695,136 |
Fair Value Measurements - Sum_2
Fair Value Measurements - Summary of Black Scholes Pricing Model Assumptions Used to Record Fair Value of Warrants (Details) - Level 3 | Jun. 30, 2022 | May 04, 2022 |
Stock Price | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants outstanding, measurement input | 0.19 | 0.14 |
Risk-free Interest Rate | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants outstanding, measurement input | 0.0301 | 0.0293 |
Expected Term | Minimum | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants outstanding, term | 4 years 10 months 24 days | 5 years |
Expected Term | Maximum | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants outstanding, term | 5 years 4 months 24 days | 5 years 6 months |
Expected Volatility | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Warrants outstanding, measurement input | 1.06 | 1.05 |
Fair Value Measurements - Sum_3
Fair Value Measurements - Summary of Change in Level 3 Warrant Liability (Details) - Level 3 $ in Thousands | 6 Months Ended |
Jun. 30, 2022 USD ($) | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Issuance of warrants | $ 2,622 |
Change in fair value | 1,023 |
Fair value of warrant liability as of the end of the period | $ 3,645 |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expenses (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Payables and Accruals [Abstract] | ||
Payroll and employee-related expenses | $ 295 | $ 371 |
Third-party research and development expenses | 2,260 | 3,195 |
Professional fees | 184 | 677 |
Loan interest | 112 | 227 |
Other | 19 | 10 |
Total accrued expenses | $ 2,870 | $ 4,480 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 USD ($) | Jun. 30, 2021 USD ($) | Jun. 30, 2022 USD ($) ft² | Jun. 30, 2021 USD ($) | |
Operating Leased Assets [Line Items] | ||||
Lease costs | $ 0.1 | $ 0.1 | $ 0.2 | $ 0.2 |
Operating lease, weighted average remaining lease term | 9 months | 9 months | ||
Operating lease, weighted average discount rate | 5.50% | 5.50% | ||
Sudbury, MA | ||||
Operating Leased Assets [Line Items] | ||||
Rentable office space under operating lease | ft² | 11,691 | |||
Base rent for office space | $ 0.3 | |||
Operating lease expiration date | Feb. 28, 2026 | |||
Right to terminate description | The Company has a one-time option to cancel the lease effective February 28, 2023 for any reason or no reason at all | |||
Newton, MA | ||||
Operating Leased Assets [Line Items] | ||||
Rentable office space under operating lease | ft² | 6,055 | |||
Base rent for office space | $ 0.3 | |||
Right to terminate description | the Newton Lease terminates on the last day of the month following the month either party notifies the other that the term of the lease shall end |
Commitments and Contingencies_2
Commitments and Contingencies - Schedule of Maturities of Operating Lease Liabilities (Details) - ASC 842 $ in Thousands | Jun. 30, 2022 USD ($) |
Lessee Lease Description [Line Items] | |
Remainder of 2022 | $ 158 |
2023 | 231 |
Total maturities | 389 |
Less: Amount representing interest | (9) |
Present value of operating lease liabilities | $ 380 |
Convertible Debt Agreement - Ad
Convertible Debt Agreement - Additional Information (Details) | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||
Sep. 29, 2020 USD ($) TradingDay Facility Installment $ / shares | Aug. 31, 2022 USD ($) | Mar. 31, 2022 USD ($) | Dec. 31, 2020 USD ($) | Jun. 30, 2022 USD ($) shares | Dec. 31, 2021 USD ($) shares | |
Debt Instrument [Line Items] | ||||||
Shares of common stock reserved for future issuances | shares | 47,600,176 | 21,805,776 | ||||
Common Stock Issuable Upon Conversion of Outstanding Debt | ||||||
Debt Instrument [Line Items] | ||||||
Shares of common stock reserved for future issuances | shares | 1,219,512 | 2,439,024 | ||||
Loan and Security Agreement | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, terms of conversion description | The Company has the right to convert at any time any portion of the then outstanding borrowings and all accrued but unpaid interest into shares of the Company’s common stock, at the applicable conversion price, subject to the fulfillment of both of the following conditions: (i) during a period of 30 consecutive trading days prior to the date on which the Company provides notice of the exercise of its conversion right, the closing price of the Company’s common stock was higher than 1.4 times the applicable conversion price of the term loans on at least 20 trading days, including on the trading day preceding the date on which the Company provides notice of the exercise of its conversion right, (ii) the number of shares of common stock issuable upon conversion by the Company shall not exceed the average weekly number of shares of the Company’s common stock traded on the stock market for the four weeks immediately preceding the date on which the Company provides notice of the exercise of its conversion right. | |||||
Debt instrument conversion threshold consecutive trading days | TradingDay | 30 | |||||
Loan and Security Agreement | Minimum | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument conversion threshold trading days | TradingDay | 20 | |||||
Loan and Security Agreement | Pontifax | ||||||
Debt Instrument [Line Items] | ||||||
Loan agreement, maximum borrowing capacity | $ 25,000,000 | |||||
Number of term loan facilities | Facility | 3 | |||||
Fixed interest rate on loan amounts outstanding | 9% | |||||
Loan and security agreement, term | 48 months | |||||
Loan and security agreement, interest only payment period | 24 months | |||||
Expiration of interest only period | Sep. 29, 2022 | |||||
Loan and security agreement, number of quarterly payments | Installment | 8 | |||||
Loan and security agreement, frequency of payments | quarterly | |||||
Conversion price for borrowings outstanding | $ / shares | $ 4.10 | |||||
Debt instrument, terms of conversion description | Pontifax, at its option, has the right to convert at any time any portion of the then outstanding borrowings and all accrued but unpaid interest into shares of the Company’s common stock, at the applicable conversion price. The conversion price for borrowings outstanding under the Pontifax Agreement is fixed at $4.10 per share. If the Company consummates a stock split, stock combination, reclassification, payment of stock dividend, recapitalization or other similar transaction (each a “Stock Event”), then the applicable conversion price will be proportionately increased or decreased as necessary to reflect the proportionate change in shares of the Company’s common stock issued and outstanding as a result of such Stock Event. | |||||
Voluntary principal repayments | $ 500,000 | $ 5,000,000 | ||||
Outstanding principal balance | $ 5,000,000 | $ 4,500,000 | $ 10,000,000 | |||
Loan and Security Agreement | Pontifax | Initial Loan | ||||||
Debt Instrument [Line Items] | ||||||
Loan agreement, advanced amount | $ 10,000,000 | |||||
Loan and Security Agreement | Pontifax | Credit Line | ||||||
Debt Instrument [Line Items] | ||||||
Loan agreement, remaining borrowing capacity | $ 5,000,000 | |||||
Loan and security agreement, percentage fee paid | 1% | |||||
Unused credit facility expiration date | Sep. 29, 2021 | |||||
Loan and Security Agreement | Pontifax | Third Installment Loan | ||||||
Debt Instrument [Line Items] | ||||||
Loan and security agreement, available borrowing capacity subject to achievement of milestones | $ 10,000,000 | $ 10,000,000 | ||||
Non-contingent, non-refundable gross proceeds from one or more equity financings and/or strategic partnerships | $ 15,000,000 | $ 15,000,000 | ||||
Unused credit facility expiration date | Dec. 29, 2021 |
Convertible Debt Agreement - Su
Convertible Debt Agreement - Summary of Minimum Aggregate Future Loan and Interest Payments (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Debt Disclosure [Abstract] | ||
2022 | $ 803 | |
2023 | 2,760 | |
2024 | 2,070 | |
Total minimum payments | 5,633 | |
Less: Amount representing interest | (633) | |
Less: Discount | (96) | |
Less: Current portion | $ (4,904) | $ (9,852) |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | |||||||||
Jul. 12, 2022 | Jul. 08, 2022 | May 03, 2022 | Dec. 31, 2021 | Jul. 16, 2021 | Mar. 31, 2022 | Mar. 31, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | May 09, 2022 | May 05, 2022 | |
Class of Stock [Line Items] | |||||||||||
Net proceeds after deducting offering costs | $ 3,944 | $ 13,464 | |||||||||
Each warrant exercisable shares | 10,687,912 | 34,383,048 | |||||||||
Exercise price of warrants | $ 1.26 | $ 0.51 | |||||||||
Common stock, voting rights | one vote for each share held | ||||||||||
Preferred stock issued | 0 | 2,872 | |||||||||
Net proceeds from issuance and sale of preferred stock | $ 2,251 | ||||||||||
Preferred stock stated value per share | $ 0.001 | $ 0.001 | |||||||||
At Market Issuance Sales Agreement | |||||||||||
Class of Stock [Line Items] | |||||||||||
Issuance of common stock, net of issuance costs, shares | 4,081,338 | ||||||||||
Securities Purchase Agreement | |||||||||||
Class of Stock [Line Items] | |||||||||||
Preferred stock issued | 2,872.1376 | ||||||||||
Preferred stock stated value per share | $ 1,000 | ||||||||||
Conversion price | 16 | ||||||||||
Warrants Expire on July 16, 2026 | |||||||||||
Class of Stock [Line Items] | |||||||||||
Exercise price of warrants | $ 1.25 | ||||||||||
Warrants exercisable shares | 10,678,872 | ||||||||||
Warrants expiration date | Jul. 16, 2026 | ||||||||||
Warrants Expire on May 1, 2026 | |||||||||||
Class of Stock [Line Items] | |||||||||||
Exercise price of warrants | $ 11.06 | ||||||||||
Warrants exercisable shares | 9,040 | ||||||||||
Warrants expiration date | May 01, 2026 | ||||||||||
Common Warrants | |||||||||||
Class of Stock [Line Items] | |||||||||||
Exercise price of warrants | $ 0.1694 | ||||||||||
Warrant issued | 22,438,575 | ||||||||||
Warrant term | 5 years | ||||||||||
HCW Warrants | |||||||||||
Class of Stock [Line Items] | |||||||||||
Exercise price of warrants | $ 0.20 | ||||||||||
Warrants expiration date | May 03, 2027 | ||||||||||
Warrant issued | 1,256,561 | ||||||||||
Warrant term | 5 years | ||||||||||
Direct Offering | |||||||||||
Class of Stock [Line Items] | |||||||||||
Issuance of common stock, net of issuance costs, shares | 17,416,096 | ||||||||||
Maximum aggregate warrant to purchase number of shares of common stock | 10,678,872 | ||||||||||
Combined price of each share of common stock and accompanying warrant to purchase one-half price per share | $ 1.311 | ||||||||||
Net proceeds after deducting offering costs | $ 25,400 | ||||||||||
Difference in combined price of each share of common stock and accompanying warrant and purchase price of prefunded warrant per share | $ 0.01 | ||||||||||
Gross proceeds of the transaction | $ 28,000 | ||||||||||
Each warrant exercisable shares | 1 | ||||||||||
Warrant exercisable date | Jul. 16, 2026 | ||||||||||
Exercise price of warrants | $ 1.25 | ||||||||||
Direct Offering | 2021 Pre-Funded Warrant | |||||||||||
Class of Stock [Line Items] | |||||||||||
Maximum aggregate warrant to purchase number of shares of common stock | 3,941,648 | ||||||||||
Purchase price of warrant | $ 1.301 | ||||||||||
Each warrant exercisable shares | 1 | ||||||||||
Warrant exercisable date | Jul. 16, 2021 | ||||||||||
Exercise price of warrants | $ 0.01 | ||||||||||
Series D and E Convertible Preferred Stock | Securities Purchase Agreement | |||||||||||
Class of Stock [Line Items] | |||||||||||
Preferred stock issued | 2,872.1376 | ||||||||||
Net proceeds from issuance and sale of preferred stock | $ 2,300 | ||||||||||
Preferred stock stated value per share | $ 1,000 | ||||||||||
Series D Preferred Stock | Securities Purchase Agreement | |||||||||||
Class of Stock [Line Items] | |||||||||||
Preferred stock stated value per share | $ 0.001 | ||||||||||
Conversion of preferred stock | 8,975,430 | 8,975,430 | |||||||||
Series E Preferred Stock | Securities Purchase Agreement | |||||||||||
Class of Stock [Line Items] | |||||||||||
Preferred stock stated value per share | $ 0.001 | ||||||||||
Conversion of preferred stock | 8,975,430 | 8,975,430 | |||||||||
Conversion price | $ 0.16 | ||||||||||
Series F Non-Convertible Preferred Stock | Subsequent Event | |||||||||||
Class of Stock [Line Items] | |||||||||||
Preferred stock stated value per share | $ 0.001 | ||||||||||
Conversion of preferred stock | 100 | ||||||||||
Convertible preferred stock shares issued for cash | $ 100,000 | ||||||||||
Preferred stock, Liquidation preference per share | $ 0.01 | ||||||||||
Preferred stock, liquidation preference aggregate value | $ 1,000 | ||||||||||
Cowen ATM Agreement | |||||||||||
Class of Stock [Line Items] | |||||||||||
Issuance of common stock, net of issuance costs, shares | 6,058,318 | ||||||||||
Net proceeds after deducting offering costs | $ 11,700 | ||||||||||
Weighted average price of common stock shares sold and issued | $ 1.99 | ||||||||||
B. Riley ATM Agreement | At Market Issuance Sales Agreement | |||||||||||
Class of Stock [Line Items] | |||||||||||
Net proceeds after deducting offering costs | $ 4,200 | ||||||||||
Weighted average price of common stock shares sold and issued | $ 1.11 | ||||||||||
Updated B. Riley ATM Agreement. | At Market Issuance Sales Agreement | |||||||||||
Class of Stock [Line Items] | |||||||||||
Issuance of common stock, net of issuance costs, shares | 6,804,888 | ||||||||||
Net proceeds after deducting offering costs | $ 3,900 | ||||||||||
Weighted average price of common stock shares sold and issued | $ 0.62 | ||||||||||
HCW ATM Agreement | Subsequent Event | |||||||||||
Class of Stock [Line Items] | |||||||||||
Issuance of common stock, net of issuance costs, shares | 14,358,057 | ||||||||||
Net proceeds after deducting offering costs | $ 1,900 | ||||||||||
Weighted average price of common stock shares sold and issued | $ 0.14 |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Shares of Common Stock Reserved (Details) - shares | Jun. 30, 2022 | Dec. 31, 2021 |
Class of Stock [Line Items] | ||
Shares of common stock reserved for future issuances | 47,600,176 | 21,805,776 |
Stock Options and Restricted Stock Units | ||
Class of Stock [Line Items] | ||
Shares of common stock reserved for future issuances | 11,691,089 | 8,372,313 |
Warrants | ||
Class of Stock [Line Items] | ||
Shares of common stock reserved for future issuances | 34,383,048 | 10,687,912 |
Common Stock Issuable Upon Conversion of Outstanding Debt | ||
Class of Stock [Line Items] | ||
Shares of common stock reserved for future issuances | 1,219,512 | 2,439,024 |
Employee Stock Purchase Plan | ||
Class of Stock [Line Items] | ||
Shares of common stock reserved for future issuances | 306,527 | 306,527 |
Stock Incentive Plans - Additio
Stock Incentive Plans - Additional Information (Details) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||||||
Feb. 01, 2022 | Jan. 01, 2022 | Jan. 01, 2021 | Jan. 01, 2020 | Oct. 31, 2017 | Mar. 31, 2022 | Jun. 30, 2022 | Dec. 31, 2020 | Jan. 22, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Number of stock options granted | 0 | ||||||||
Restricted Stock Units (RSUs) | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Stock-based award, vesting period | 3 years | ||||||||
Unrecognized stock-based compensation expense, weighted average period for recognition | 2 years 6 months | ||||||||
RSUs granted | 2,998,500 | 2,998,500 | |||||||
Share-based payment arrangement, unvested award, unrecognized, amount | $ 0.7 | ||||||||
2011 Plan | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Number of shares authorized for grant | 0 | ||||||||
2017 Plan | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Stock option grant effective date | Oct. 31, 2017 | ||||||||
Share based award, description | Upon the adoption of the 2017 Plan, no further grants would be made under the 2011 Stock Incentive Plan (“2011 Plan”). The 2017 Plan initially provided for the grant of awards for 2,038,021 shares of common stock. In addition to the shares available for grant under the 2017 Plan, shares underlying any awards outstanding under the 2011 Plan as of October 31, 2017 that are cancelled, forfeited or otherwise terminated without being exercised will be available for future grant under the 2017 Plan. The 2017 Plan also provides that an additional number of shares will automatically be added to the shares authorized for issuance under the 2017 Plan on January 1 of each year. The number of shares added each year will be equal to the lesser of: (i) 4% of the outstanding shares on the immediately preceding December 31 or (ii) such amount as determined by the Compensation Committee of the registrant’s Board of Directors. On January 1, 2020, 2021 and 2022, the shares available for grant under the 2017 Plan were automatically increased by 989,400, 2,032,854 and 3,318,776 shares, respectively. | ||||||||
Percentage criteria for additional shares granted | 4% | ||||||||
Additional shares available for grant | 3,318,776 | 2,032,854 | 989,400 | ||||||
2017 Plan | Stock Options | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Shares available for future grant | 3,016,640 | ||||||||
Stock-based award, vesting period | 4 years | ||||||||
2017 Plan | Common Stock | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Number of shares authorized for grant | 2,038,021 | ||||||||
2021 Plan | Common Stock | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Number of shares authorized for grant | 1,600,000 | ||||||||
Shares available for future grant | 1,145,000 | ||||||||
2011, 2017 and 2021 Plans | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Unrecognized stock-based compensation expense related to unvested employee stock options | $ 3.1 | ||||||||
Unrecognized stock-based compensation expense, weighted average period for recognition | 2 years 2 months 12 days | ||||||||
2011, 2017 and 2021 Plans | Stock Options | Maximum | |||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||||
Stock-based award, expiration period | 10 years |
Stock Incentive Plans - Summary
Stock Incentive Plans - Summary of Stock-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 560 | $ 960 | $ 1,177 | $ 1,827 |
Research and Development | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Stock-based compensation expense | 135 | 303 | 305 | 550 |
General and Administrative | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 425 | $ 657 | $ 872 | $ 1,277 |
Stock Incentive Plans - Schedul
Stock Incentive Plans - Schedule of Assumptions Used in Black-Scholes Option Pricing Model to Estimate Fair Value of Stock Options (Details) - Stock Options - Employees and Directors | 3 Months Ended | 6 Months Ended |
Jun. 30, 2021 | Jun. 30, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Risk-free interest rate, minimum | 0.90% | 0.40% |
Risk-free interest rate, maximum | 1.40% | 1.40% |
Expected volatility, minimum | 93% | 93% |
Expected volatility, maximum | 94% | 94% |
Minimum | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected term (in years) | 5 years 4 months 24 days | 5 years |
Maximum | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected term (in years) | 7 years | 7 years |
Stock Incentive Plans - Summa_2
Stock Incentive Plans - Summary of Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended |
Mar. 31, 2022 | Jun. 30, 2022 | Dec. 31, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Shares, Granted | 0 | ||
2011, 2017 and 2021 Plans | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Shares, Outstanding, Beginning balance | 6,765,837 | 6,765,837 | |
Shares, Forfeited | (1,316,712) | ||
Shares, Expired | (13,176) | ||
Shares, Outstanding, Ending balance | 5,435,949 | 6,765,837 | |
Shares, Exercisable | 3,417,270 | ||
Weighted-Average Exercise Price, Outstanding, Beginning balance | $ 2.81 | $ 2.81 | |
Weighted-Average Exercise Price, Forfeited | 2.54 | ||
Weighted-Average Exercise Price, Expired | 0.42 | ||
Weighted-Average Exercise Price, Outstanding, Ending balance | 2.88 | $ 2.81 | |
Weighted-Average Exercise Price, Exercisable | $ 3.31 | ||
Weighted-Average Remaining Contractual Life (in years), Outstanding | 7 years | 7 years 7 months 6 days | |
Weighted-Average Remaining Contractual Life (in years), Exercisable | 6 years 2 months 12 days | ||
Aggregate Intrinsic Value, Outstanding | $ 0 | $ 3 | |
Aggregate Intrinsic Value, Exercisable | $ 0 |
Stock Incentive Plans - Summa_3
Stock Incentive Plans - Summary of Nonvested RSUs (Details) - Restricted Stock Units (RSUs) - $ / shares | 6 Months Ended | |
Feb. 01, 2022 | Jun. 30, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Shares, Outstanding, Beginning balance | 0 | |
Shares, Granted | 2,998,500 | 2,998,500 |
Shares, Forfeited | (905,000) | |
Shares, Outstanding, Ending balance | 2,093,500 | |
Weighted-Average Grant Date Fair Value, Outstanding, Beginning balance | $ 0 | |
Weighted-Average Grant Date Fair Value, Granted | 0.40 | |
Weighted-Average Grant Date Fair Value, Forfeited | 0.40 | |
Weighted-Average Grant Date Fair Value, Outstanding, Ending balance | $ 0.40 |